[Federal Register Volume 66, Number 206 (Wednesday, October 24, 2001)]
[Notices]
[Pages 53836-53927]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-26650]
[[Page 53835]]
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Part II
Department of Health and Human Services
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Food and Drug Administration
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Annual Comprehensive List of Guidance Documents at the Food and Drug
Administration; Notice
Federal Register / Vol. 66, No. 206 / Wednesday, October 24, 2001 /
Notices
[[Page 53836]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98N-0046]
Annual Comprehensive List of Guidance Documents at the Food and
Drug Administration
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is publishing its
annual comprehensive list of all guidance documents currently in use at
the agency. This list is being published under 21 CFR 10.115(n)(2) of
FDA's regulation on Good Guidance Practices (GGPs). This list is
intended to inform the public of the existence and availability of all
of our current guidance documents. It also provides information on
guidance documents that have been added or withdrawn in the past year.
DATES: We welcome general comments on this list and on agency guidance
documents at any time.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit electronic comments to http://www.fda.gov.dockets/ecomments. We have provided information in the
tables below on where to obtain a single copy of any of the guidance
documents listed.
FOR FURTHER INFORMATION CONTACT: Carol A. Kimbrough, Office of Policy,
Planning, and Legislation (HF-26), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-3480.
SUPPLEMENTARY INFORMATION:
I. Background
We published our final rule on GGPs in the Federal Register of
September 19, 2000 (65 FR 56468), and they became effective October 19,
2000. GGPs are intended to ensure involvement of the public in the
development of guidance documents, and to enhance understanding of the
availability, nature, and legal effect of such guidance. We committed
in the GGPs to publishing annually a comprehensive list of guidance
documents. This list updates a comprehensive list published July 21,
2000 (65 FR 45428).
The following comprehensive list identifies all final guidances
that have been issued and are in use, and all draft guidances that have
been distributed for comment and not for implementation. Any guidances
that have been withdrawn this year are also listed. We have organized
the documents by the issuing Center or Office within FDA, and we have
identified the pertinent intended users or regulatory activities. The
dates in the list refer to the date we issued the guidances or, where
applicable, the last date we revised a document. Because each issuing
Center or Office maintains its own database, there are slight
variations in the way in which they provide information on the tables
below.
The following most frequently used Internet sites for agency
guidances are provided for future reference:
CBER: http://www.fda.gov/cber/guidelines.htm
CDER: http://www.fda.gov/cder/guidance/index.htm
CDRH: http://www.fda.gov/cdrh/guidance.html
CFSAN: http://www.cfsan.fda.gov/6dms/guidance.html
CVM: http://www.fda.gov/cvm/guidance/published.htm#documents
ORA: http://www.fda.gov/ora/compliance--;ref
II. Guidance Documents Issued by the Center for Biologics Evaluation and Research (CBER)
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Intended User or Regulatory
Name of Document Date of Issuance Activity How to Obtain a Hard Copy of the Document
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Interpretative Guidelines of the Source Plasma October 2, 1973 FDA Regulated Industry Office of Communication, Training, and
(Human) Standards Manufacturers Assistance (HFM-40), Center for
Biologics Evaluation and Research (CBER), Food
and Drug Administration, 1401 Rockville Pike,
Rockville, MD 20852-1448, 1-800-835-4709 or
301-827-1800, FAX Information System: 1-888-
CBER-FAX (within U.S.) or 301-827-3844
(outside U.S. and local to Rockville, MD).
Internet access: http://www.fda.gov/cber
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Guidelines for Reviewing Amendments to Include July 20, 1976 Do Do
Plasmapheresis of Hemophiliacs
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Package Insert: Immune Serum Globulin (Human) March 30, 1978 Do Do
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Guidelines for Interpretation of Potency Test April 12, 1979 Do Do
Results for All Forms of Adsorbed Diphtheria
and Tetanus Toxoids
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Guidelines for Immunization of Source Plasma June 1, 1980 Do Do
(Human) Donors With Blood Substances
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Collection of Human Leukocytes for Further January 28, 1981 Do Do
Manufacturing (Source Leukocytes)
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Platelet Testing Guidelines--Approval of New July 1, 1981 Do Do
Procedures and Equipment
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[[Page 53837]]
Revised Guideline for Adding Heparin to Empty August 1, 1981 Do Do
Containers for Collection of Heparinized
Source Plasma (Human)
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Requirements for Infrequent Plasmapheresis August 27, 1982 Do Do
Donors
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Recommendations to Decrease the Risk of March 24, 1983 Do Do
Transmitting AIDS From Plasma Donors
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PTC in the Manufacture of In Vitro Monoclonal June 20, 1983 Do Do
Antibody Products Subject to Licensure
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Draft PTC in the Production and Testing of July 28, 1983 Do Do
Interferon Intended for Investigational Use in
Humans (Interferon Test Procedures)
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Interstate Shipment of Interferon for November 21, 1983 Do Do
Investigational Use in Laboratory Research
Animals or Tests in Vitro
--------------------------------------------------------------------------------------------------------------------------------------------------------
Deferral of Blood Donors Who Have Received the February 28, 1984 Do Do
Drug Accutane (Isotretinoin/Roche); 13-cis-
retinoic acid)
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Equivalent Methods for Compatibility Testing December 14, 1984 Do Do
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Plasma Derived From Therapeutic Plasma Exchange December 14, 1984 Do Do
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Draft PTC in the Production and Testing of New April 10, 1985 Do Do
Drugs and Biologicals Produced by Recombinant
DNA Technology
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Guidelines for Meningococcal Polysaccharide July 17, 1985 Do Do
Vaccines
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Guideline for the Uniform Labeling of Blood and August 1, 1985 Do Do
Blood Components
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Recommended Methods for Short Ragweed Pollen November 1, 1985 Do Do
Extracts
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Reduction of the Maximum Platelet Storage June 2, 1986 Do Do
Period to 5 Days in an Approved Container
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To In Vitro Diagnostic Reagent Manufacturers: December 6, 1986 Do Do
Guidance on the Labeling of Human Blood
Derived in Vitro Diagnostic Devices in Regard
to Labeling for HTLV-III/LAV Antibody Testing
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Guideline for Submitting Documentation for the February 1, 1987 Do Do
Stability of Human Drugs and Biologics
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Guideline for Submitting Documentation for February 1, 1987 Do Do
Packaging for Human Drugs and Biologics
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Guideline on General Principles of Process May 1, 1987 Do Do
Validation
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Guideline on Sterile Drug Products Produced by June 1, 1987 Do Do
Aseptic Processing
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[[Page 53838]]
Deferral of Donors Who Have Received Human November 25, 1987 Do Do
Pituitary-Derived Growth Hormone
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Guideline on Validation of the Limulus December 1, 1987 Do Do
Amebocyte Lysate Test as an End-Product
Endotoxin Test for Human and Animal Parenteral
Drugs, Biological Products, and Medical
Devices
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Recommendations for the Management of Donors December 2, 1987 Do Do
and Units That Are Initially Reactive for
Hepatitis B Surface Antigen (HBsAg)
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Extension of Dating Period for Storage of Red December 4, 1987 Do Do
Blood Cells, Frozen
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To Licensed In Vitro Diagnostic Manufacturers: December 23, 1987 Do Do
Handling of Human Blood Source Materials
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Recommendations for Implementation of April 6, 1988 Do Do
Computerization in Blood Establishments
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Control of Unsuitable Blood and Blood April 6, 1988 Do Do
Components
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Discontinuance of Prelicensing Inspection for July 7, 1988 Do Do
Immunization Using Licensed Tetanus Toxoid and
Hepatitis B and Rabies Vaccines
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Physician Substitutes August 15, 1988 Do Do
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To Licensed Manufacturers of Blood Grouping August 26, 1988 Do Do
Reagents: Criteria for Exemption of Lot
Release
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Revised Guideline for the Collection of October 7, 1988 Do Do
Platelets, Pheresis
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To Manufacturers of HTLV-I Antibody Test Kits: October 18, 1988 Do Do
Antibody to Human T-Cell Lymphotropic Virus,
Type I (HTLV-I) Release Panel I
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Draft Guideline for the Design of Clinical November 1, 1988 Do Do
Trials for Evaluation of Safety and Efficacy
of Allergenic Products for Therapeutic Uses
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HTLV-I Antibody Testing November 29, 1988 Do Do
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Use of Recombigen HIV-1 LA Test February 1, 1989 Do Do
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Guidelines for Release of Pneumococcal Vaccine, February 1, 1989 Do Do
Polyvalent
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Guidance for Autologous Blood and Blood March 15, 1989 Do Do
Components
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HTLV-I Antibody Testing July 6, 1989 Do Do
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Use of Recombigen HIV-1 Latex Agglutination August 1, 1989 Do Do
(LA) Test
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Draft PTC in the Manufacture and Clinical August 8, 1989 Do Do
Evaluation of In Vitro Tests to Detect
Antibodies to Human Immunodeficiency Virus
Type 1 (1989)
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[[Page 53839]]
PTC in the Collection, Processing and Testing August 22, 1989 Do Do
of Ex Vivo Activated Mononuclear Leukocytes
for Administration to Humans
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Information Relevant to the Manufacture of August 23, 1989 Do Do
Acellular Pertussis Vaccine
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FDA Regulated Industries for Drug Master Files September 1, 1989 Do Do
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Requirements for Computerization of Blood September 8, 1989 Do Do
Establishments
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Abbott Laboratories' HIVAG-1 Test for HIV-1 October 4, 1989 Do Do
Antigen(s) Not Recommended for Requirements
for Computerization of Blood Establishments
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Guideline for Collection of Blood or Blood October 26, 1989 Do Do
Products From Donors With PositiveTests for
Infectious Disease Markers (``High Risk''
Donors)
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Guideline for Determination of Residual January 1, 1990 Do Do
Moisture in Dried Biological Products
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Autologous Blood Collection and Processing February 12, 1990 Do Do
Procedures
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Cytokine and Growth Factor Pre-Pivotal Trial April 2, 1990 Do Do
Information Package
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Use of Genetic Systems HIV-2 EIA June 21, 1990 Do Do
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PTC in the Safety Evaluation of Hemoglobin- August 21, 1990 Do Do
Based Oxygen Carriers
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Guideline on the Preparation of Investigational March 1, 1991 Do Do
New Drug Products (Human and Animal)
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FDA Request for Information on Blood Storage March 15, 1991 Do Do
Patterns and Red Cell Contamination by
Yersinia Enterocolitica
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Revision to October 26, 1989, Guideline for March 17, 1991 Do Do
Collection of Blood or Blood Products From
Donors With Positive Tests for Infectious
Disease Markers (High Risk Donors)
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Deficiencies Relating to the Manufacture of March 20, 1991 Do Do
Blood and Blood Components
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Responsibilities of Blood Establishments March 20, 1991 Do Do
Related to Errors and Accidents in the
Manufacture of Blood and Blood Components
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To Biologic Product Manufacturers--Controlling May 3, 1991 Do Do
Materials of Bovine or Ovine Origin
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FDA Recommendations Concerning Testing for September 10, 1991 Do Do
Antibody to Hepatitis B Core Antigen (Anti-
HBc)
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Disposition of Blood Products Intended for September 11, 1991 Do Do
Autologous Use That Test Repeatedly Reactive
for Anti-HCV
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[[Page 53840]]
Clarification of FDA Recommendations for Donor December 12, 1991 Do Do
Deferral and Product Distribution Based on the
Results of Syphilis Testing
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Recommended Methods for Blood Grouping Reagents March 1, 1992 Do Do
Evaluation
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Recommended Methods for Evaluating Potency, March 1, 1992 Do Do
Specificity and Reactivity of Anti-Human
Globulin
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PTC in the Design and Implementation of Field March 1, 1992 Do Do
Trials for Blood Grouping Reagents and Anti-
Human Globulin
--------------------------------------------------------------------------------------------------------------------------------------------------------
PTC in the Manufacture of In Vitro Monoclonal March 1, 1992 Do Do
Antibody Products for Further Manufacturing
into Blood Grouping Reagent and Anti-Human
Globulin
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Supplement to the PTC in the Production and April 6, 1992 Do Do
Testing of New Drugs and Biologicals Produced
by Recombinant DNA Technology: Nucleic Acid
Characterization and Genetic Stability
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Revised Recommendations for the Prevention of April 23, 1992 Do Do
Human Immunodeficiency Virus (HIV)
Transmission by Blood and Blood Products
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Use of Fluorognost HIV-1 Immunofluorescent April 23, 1992 Do Do
Assay (IFA)
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Revised Recommendations for Testing Whole April 23, 1992 Do Do
Blood, Blood Components, Source Plasma and
Source Leukocytes for Antibody to Hepatitis C
Virus Encoded Antigen (Anti-HCV)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Exemptions to Permit Persons With a History of April 23, 1992 Do Do
Viral Hepatitis Before the Age of Eleven Years
to Serve as Donors of Whole Blood and Plasma;
Alternative Procedures, 21 CFR 640.120
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Changes in Equipment for Processing Blood Donor July 21, 1992 Do Do
Samples
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Nomenclature for Monoclonal Blood Grouping September 28, 1992 Do Do
Reagents
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Volume Limits for Automated Collection of November 4, 1992 Do Do
Source Plasma
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FDA's Policy Statement Concerning Cooperative November 25, 1992 Do Do
Manufacturing Arrangements for Licensed
Biologics
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Revision of October 7, 1988, Memo Concerning December 16, 1992 Do Do
Red Blood Cell Immunization Programs
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Draft PTC in the Characterization of Cell Lines July 12, 1993 Do Do
Used to Produce Biologicals
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CBER Refusal to File (RTF) Guidance for Product July 12, 1993 Do Do
and Establishment License Applications
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[[Page 53841]]
Guidance on Alternatives to Lot Release for July 20, 1993 Do Do
Licensed Biological Products
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Recommendations Regarding License Amendments July 22, 1993 Do Do
and Procedures for Gamma Irradiation of Blood
Products
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Deferral of Blood and Plasma Donors Based on July 28, 1993 Do Do
Medications
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Revised Recommendations for Testing Whole August 19, 1993 Do Do
Blood, Blood Components, Source Plasma and
Source Leukocytes for Antibody to Hepatitis C
Virus Encoded Antigen (Anti-HCV)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Changes in Administrative Procedures September 9, 1993 Do Do
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To Sponsors of INDs Using Retroviral Vectors September 20, 1993 Do Do
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Draft Guideline for the Validation of Blood September 28, 1993 Do Do
Establishment Computer Systems
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Methods of the Allergenic Products Testing October 1, 1993 Do Do
Laboratory
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Application of Current Statutory Authorities to October 14, 1993 Do Do
Human Somatic Cell Therapy Products and Gene
Therapy Products; Notice
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline for Adverse Experience Reporting for October 15, 1993 Do Do
Licensed Biological Products
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Guidance Regarding Post Donation Information December 10, 1993 Do Do
Reports
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To Manufacturers: Bovine Derived Materials December 17, 1993 Do Do
(BSE)
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Donor Suitability Related to Laboratory Testing December 22, 1993 Do Do
for Viral Hepatitis and a History of Viral
Hepatitis
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Compliance Program Guidance Manual (Drugs and 1994 Do National Technical Information Service (NTIS),
Biologics) 5285 Port Royal Rd., Springfield, VA 22161,
703-605-6050 (NTIS Order No. 94-920699)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recommendations for the Invalidation of Test January 3, 1994 Do Office of Communication, Training, and
Results When Using Licensed Viral Marker Manufacturers Assistance (HFM-40), Center for
Assays to Screen Donors Biologics Evaluation and Research (CBER), Food
and Drug Administration, 1401 Rockville Pike,
Rockville, MD 20852-1448, 1-800-835-4709 or
301-827-1800, FAX Information System: 1-888-
CBER-FAX (within U.S.) or 301-827-3844
(outside U.S. and local to Rockville, MD).
Internet access: http://www.fda.gov/cber
--------------------------------------------------------------------------------------------------------------------------------------------------------
To Sponsors of INDs for Human Immunoglobulin May 23, 1994 Do Do
Products
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To Manufacturers of Licensed Anti-HIV Test Kits May 26, 1994 Do Do
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Recommendations for Deferral of Donors for July 26, 1994 Do Do
Malaria Risk
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[[Page 53842]]
ICH Guideline for Industry: Studies in Support August 1, 1994 Do Do
of Special Populations
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OELPS, Advertising and Promotional Labeling August 1, 1994 Do Do
Staff Procedural Guidance Document (Draft)
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Guideline for Industry: Stability Testing September 1, 1994 Do Do
of New Drug Substances and Products
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Guide to Inspections of Blood Banks, Division September 1, 1994 FDA Personnel Do
of Field Investigations, Office of Regional
Operations, Office of Regulatory Affairs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter to Manufacturers of Immune Globulin October 3, 1994 FDA Regulated Industry Do
Intravenous (Human) (IGIV), Aseptic Meningitis
Syndrome
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Guidance on Alternatives to Lot Release for October 27, 1994 Do Do
Licensed Biological Products
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Guidance for Industry: For the Submission of November 1994 Do Do
Chemistry, Manufacturing, and Controls
Information for Synthetic Peptide Substances
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recommendations to Users of Medical Devices December 20, 1994 Do Do
That Test for Infectious Disease Markers by
Enzyme Immunoassay (EIA) Test Systems
--------------------------------------------------------------------------------------------------------------------------------------------------------
To Manufacturers of Immune Globulin Products: December 27, 1994 Do Do
Testing for Hepatitis C Virus RNA
Immunoglobulin
--------------------------------------------------------------------------------------------------------------------------------------------------------
Timeframe for Licensing Irradiated Blood February 3, 1995 Do Do
Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Home Specimen Collection Kit Systems Intended February 23, 1995 Do Do
for Human Immunodeficiency Virus (HIV-1 and/or
HIV-2) Antibody Testing; Revisions to Previous
Guidance
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Guideline for Industry: Clinical Safety March 1, 1995 Do Do
Data Management: Definitions and Standards for
Expedited Reporting
--------------------------------------------------------------------------------------------------------------------------------------------------------
To Manufacturers of Intramuscular Immune March 3, 1995 Do Do
Globulin Products: HCV RNA Testing by PCR
--------------------------------------------------------------------------------------------------------------------------------------------------------
Revision of 8/27/82 FDA Memo: Requirements for March 10, 1995 Do Do
Infrequent Plasmapheresis Donors
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To Manufacturers of Intramuscular Immune March 13, 1995 Do Do
Globulin Products: Additional Information
Regarding HCV RNA Testing by PCR
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To Health Professionals: Implementation of March 14, 1995 Do Do
Testing for HCV RNA by PCR for Immune Globulin
Products for Intramuscular Administration
--------------------------------------------------------------------------------------------------------------------------------------------------------
To All Establishments Performing Red Blood Cell March 14, 1995 Do Do
Immunizations: Revised Recommendations for Red
Blood Cell Immunization Programs for Source
Plasma
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[[Page 53843]]
Recommendations for the Deferral of Current and June 8, 1995 Do Do
Recent Inmates of Correctional Institutions as
Donors of Whole Blood, Blood Components,
Source Leukocytes and Source Plasma
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Guideline for Quality Assurance in Blood July 11, 1995 Do Do
Establishments
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FDA Guidance Document Concerning Use of Pilot July 11, 1995 Do Do
Manufacturing Facilities for the Development
and Manufacture of Biological Products
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Disposition of Products Derived From Donors August 8, 1995 Do Do
Diagnosed With, or at Known High Risk for,
Creutzfeldt-Jakob Disease
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Recommendations for Labeling and Use of Units August 8, 1995 Do Do
of Whole Blood, Blood Components, Source
Plasma, Recovered Plasma or Source Leukocytes
Obtained From Donors With Elevated Levels of
Alanine Aminotransferase (ALT)
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Precautionary Measures to Further Reduce the August 8, 1995 Do Do
Possible Risk of Transmission of Creutzfeldt-
Jakob Disease by Blood and Blood Products
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Recommendations for Donor Screening With a August 8, 1995 Do Do
Licensed Test for HIV-1 Antigen
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PTC in the Manufacture and Testing of August 22, 1995 Do Do
Therapeutic Products for Human Use Derived
From Transgenic Animals
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Informed Consent for Plasmapheresis/ October 1, 1995 FDA Personnel Do
Immunization
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Draft Reviewers' Guide: Changes in Personnel October 1, 1995 FDA Personnel Do
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Disease Associated Antibody Collection Program October 1, 1995 FDA Personnel Do
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Guidance Concerning Conversion to FDA-Reviewed November 13, 1995 FDA Regulated Industry Do
Software Products
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Donor Deferral Due to Red Blood Cell Loss December 4, 1995 Do Do
During Collection of Source Plasma by
Automated Plasmapheresis
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Interim Definition and Elimination of Lot-by- December 8, 1995 Do Do
Lot Release for Well-Characterized Therapeutic
Recombinant DNA-Derived and Monoclonal
Antibody Biotechnology Products
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Dear Colleague: Regarding Reverse Transcriptase January 4, 1996 Do Do
Activity in Viral Vaccines Produced in Chicken
Cells
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Requesting All Manufacturers Immediately to January 4, 1996 Do Do
Revise Warning Section for Package Insert on
Thrombin
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ICH Final Guideline: Quality of February 23, 1996 Do Do
Biotechnological Products: Analysis of the
Expression Construct in Cells Used for
Production of r-DNA Dervied Protein Products
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[[Page 53844]]
ICH Final Guideline on the Need for Long-Term March 1, 1996 Do Do
Rodent Carcinogenicity Study of
Pharmaceuticals
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Additional Recommendations for Donor Screening March 14, 1996 Do Do
With a Licensed Test for HIV-1 Antigen
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FDA Guidance Concerning Demonstration of March 26, 1996 Do Do
Comparability of Human Biological Products,
Including Therapeutic Biotechnology-Derived
Products
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ICH Guideline on the Detection of Toxicity to April 5, 1996 Do Do
Reproduction for Medicinal Products; Addendum
on Toxicity to Male Fertility
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ICH Guidance on Specific Aspects of Regulatory April 24, 1996 Do Do
Genotoxicity Tests for Pharmaceuticals
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To Manufacturers of FDA-Regulated Drug/ May 9, 1996 Do Do
Biological/Device Products, Bovine Spongiform
Encephalopathy (BSE)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Additional Recommendations for Testing Whole May 16, 1996 Do Do
Blood, Blood Components, Source Plasma and
Source Leucocytes for Antibody to Hepatitis C
Virus Encoded Antigen (Anti-HCV)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--The Content and Format May 23, 1996 Do Do
for Pediatric Use Supplements
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Guidance on Applications for Products Comprised May 24, 1996 Do Do
of Living Autologous Cells Manipulated Ex Vivo
and Intended for Structural Repair of
Reconstruction
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recommendations and Licensure Requirements for May 29, 1996 Do Do
Leukocyte-Reduced Blood Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Infectious Disease June 1, 1996 FDA Personnel Do
Marker Testing Facilities
--------------------------------------------------------------------------------------------------------------------------------------------------------
To Manufacturers: Implementation of Testing for June 13, 1996 FDA Regulated Industry Do
Hepatitis C Virus RNA by Manufacturers:
Implementation of Testing for Hepatitis C
Virus RNA by Polymerase Chain Reaction (PCR)
of Intramuscular Immune Globulin Preparations
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Final Guidelines on Stablity Testing of July 10, 1996
Biotechnological/Biological Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Guideline on Structure and Content of July 17, 1996 Do Do
Clinical Study Reports
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recommendations for the Quarantine and July 19, 1996 Do Do
Disposition of Units From Prior Collections
From Donors With Repeatedly Reactive Screening
Tests for Hepatitis B Virus (HBV), Hepatitis C
Virus (HCV) and Human T-Lymphotropic Virus
Type I (HTLV-I)
--------------------------------------------------------------------------------------------------------------------------------------------------------
To Manufacturers: HIV-1 Group O July 31, 1996 Do Do
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[[Page 53845]]
Guidance for Industry for the Submission of August 15, 1996 Do Do
Chemistry, Manufacturing, and Controls
Information for a Therapeutic Recombinant DNA-
Derived Product or a Monoclonal Antibody
Product for In Vivo Use
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Revised Guidance: Single Dose Acute August 26, 1996 Do Do
Toxicity Testing for Pharmaceuticals
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Draft Guideline on Data Elements for October 1, 1996 Do Do
Transmission of Individual Case Reports
--------------------------------------------------------------------------------------------------------------------------------------------------------
To All Plasma Derivative Manufacturers and to October 7, 1996 Do Do
ABRA: Warning Statement for Plasma Derivative
Product Labeling
--------------------------------------------------------------------------------------------------------------------------------------------------------
Advertising and Promotion; Guidance; Notice October 8, 1996 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
To Biologic Product Manufacturers: Revised December 3, 1996 Do Do
Procedures for Internal Labeling Review Number
Assignment
--------------------------------------------------------------------------------------------------------------------------------------------------------
Interim Recommendations for Deferral of Donors December 11, 1996 Do Do
at Increased Risk for HIV-1 Group O Infection
--------------------------------------------------------------------------------------------------------------------------------------------------------
PTC on Plasmid DNA Vaccines for Preventive December 22, 1996 Do Do
Infectious Disease Indications
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Submission of Chemistry, January 1997 Do Do
Manufacturing, and Controls Information and
Establishment Description for Autologous
Somatic Cell Therapy Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reviewer Guidance for a Premarket Notification January 13, 1997 FDA Personnel Do
Submission for Blood Establishment Computer
Software
--------------------------------------------------------------------------------------------------------------------------------------------------------
PTC in the Manufacturing and Testing of February 28, 1997 Do Do
Monoclonal Antibody Products for Human Use
--------------------------------------------------------------------------------------------------------------------------------------------------------
Proposed Approach to Regulation of Cellular and February 27, 1997 Do Do
Tissue-Based Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tables 1 and 2 From Proposed Approach to March 4, 1997 Do Do
Regulation of Cellular and Tissue-Based
Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Preclearance of Promotional Labeling; March 5, 1997 Do Do
Clarification
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry for the Evaluation of April 1997 Do Do
Combination Vaccines for Preventable Diseases:
Production, Testing and Clinical Studies
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Draft Guideline on Dose Selection for April 2, 1997 Do Do
Carcinogenicity Studies for Pharmaceuticals:
Addendum on the Limit Dose
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Draft Guideline on the Timing of May 2, 1997 Do Do
Nonclinical Studies for the Conduct of Human
Clinical Trials for Pharmaceuticals
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Draft Guideline on Impurities: Residual May 2, 1997 (Correction Do Do
Solvents May 19, 1997)
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53846]]
ICH Guideline on Stability Testing for New May 9, 1997 Do Do
Dosage Forms
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Draft Guideline on Statistical Principles May 9, 1997 Do Do
for Clinical Trials, Part III
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Good Clinical Practice: Consolidated May 9, 1997 Do Do
Guideline, Part II
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Guideline for the Photostability Testing of May 16, 1997 Do Do
New Drug Substances and Products, Part II
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Guideline on Impurities in New Drug May 19, 1997 Do Do
Products, Part IV
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Guideline on Clinical Safety Data May 19, 1997 Do Do
Management: Periodic Safety Update Reports for
Marketed Drugs, Part VI
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Guideline on the Validation of Analytical May 19, 1997 Do Do
Procedures: Methodology, Part V
--------------------------------------------------------------------------------------------------------------------------------------------------------
To Plasma Fractionators--CBER's View on Product May 29, 1997 Do Do
Recalls Conducted by the Plasma Fractionation
Industry
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Draft Guideline on General Considerations May 30, 1997 Do Do
for Clinical Trials
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Source Plasma June 1, 1997 FDA Personnel Do
Establishments (Division of Field
Investigations, Office of Regional Operations,
Office of Regulatory Affairs)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Computerized June 18, 1997 FDA Regulated Industry Do
Systems Used in Clinical Trials; Availability
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Changes to an Approved July 1997 Do Do
Application: Biological Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Changes to an Approved July 1997 Do Do
Application for Specified Biotechnology and
Specified Synthetic Biological Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Screening and Testing of July 1997 Do Do
Donors of Human Tissue Intended for
Transplantation
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Donor Screening for August 1997 Do Do
Antibodies to HTLV-II
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Postmarketing Adverse August 1997 Do Do
Experience Reporting for Human Drug and
Licensed Biological Products: Clarification of
What to Report
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry Efficacy Evaluation September 1997 Do Do
of Hemoglobin- and Perfluorocarbon-Based
Oxygen Carriers
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--The Sourcing and September 1997 Do Do
Processing of Gelatin to Reduce the Potential
Risk Posed by Bovine Spongiform Encephalopathy
(BSE) in FDA-Regulated Products for Human Use
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53847]]
Notification Process for Transfusion Related October 7, 1997 Do Do
Fatalities and Donation Related Deaths
(revised telephone number)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submission Requirements for Requesting October 15, 1997 Do Do
Certificates for Exporting Products to Foreign
Countries
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Guidance on Preclinical Safety Evaluation November 18, 1997 Do Do
of Biotechnology-Derived Pharmaceuticals
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Guidance on Genotoxicity: A Standard November 21, 1997 Do Do
Battery for Genotoxicity Testing for
Pharmaceuticals
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Guidance on Nonclinical Safety Studies for November 25, 1997 Do Do
the Conduct of Human Clinical Trials for
Pharmaceuticals
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for FDA and Industry: Direct Final November 21, 1997 FDA Personnel and Regulated Do
Rule Procedures Industry
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Promoting Medical December 1997 FDA Regulated Industry Do
Products in a Changing Healthcare Environment;
I. Medical Product Promotion by Healthcare
Organizations or Pharmacy Benefits Management
Companies (PBMS)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Industry-Supported December 3, 1997 Do Do
Scientific and Educational Activities
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Guidance on Dose Selection for December 4, 1997 Do Do
Carcinogenicity Studies of Pharmaceuticals:
Addendum on a Limit Dose and Related Notes
--------------------------------------------------------------------------------------------------------------------------------------------------------
To Biologic Product Manufacturers--Withdrawal December 11, 1997 Do Do
of Human Blood-Derived Materials Because
Donors Diagnosed With, or at Increased Risk
for, CJD
--------------------------------------------------------------------------------------------------------------------------------------------------------
To Allergenic Extract Manufacturers-- December 23, 1997 Do Do
Standardized Grass Pollen Extracts
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Guidance on Data Elements for Transmission January 15, 1998
of Individual Case Safety Reports
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Year 2000 Date Change January 1998 Do Do
for Computer Systems and Software Applications
Used in the Manufacture of Blood Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Container and January 1998 Do Do
Closure Integrity Testing in Lieu of Sterility
Testing as a Component of the Stability
Protocol for Sterile Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Guidance on Testing for Carcinogenicity of February 28, 1998
Pharmaceuticals
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Manufacturing, March 1998 Do Do
Processing or Holding Active Pharmaceutical
Ingredients
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Guidance for Human March 1998 Do Do
Somatic Cell Therapy and Gene Therapy
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53848]]
Draft Guidance for Industry: Instructions for May 1998 Do Do
Submitting Electronic Lot Release Protocols to
the Center for Biologics Evaluation and
Research
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Pilot Program for May 1998 Do Do
Electronic Investigational New Drug (eIND)
Applications for Biological Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Classifying May 1998 Do Do
Resubmissions in Response to Action Letters
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Pharmacokinetics in May 1998 Do Do
Patients With Impaired Renal Function--Study
Design, Data Analysis and Impact on Dosing and
Labeling
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Standards for the Prompt May 1998 Do Do
Review of Efficacy Supplements, Including
Priority Efficacy Supplements
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Providing Clinical May 1998 Do Do
Evidence of Effectiveness for Human Drugs and
Biological Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Stability Testing June 1998 Do Do
of Drug Substances and Drug Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Qualifying for Pediatric June 1998 Do Do
Exclusivity Under Section 505A of the Federal
Food, Drug, and Cosmetic Act
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Errors and Accidents June 1998 Do Do
Regarding Saline Dilution of Samples Used for
Viral Marker Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Draft Guidance on Specifications: Test June 9, 1998 Do Do
Procedures and Acceptance Criteria for
Biotechnological/Biological Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Guidance on Ethnic Factors in the June 10, 1998 Do Do
Acceptability of Foreign Clinical Data
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Exports and June 12, 1998 Do Do
Imports Under the FDA Export Reform and
Enhancement Act of 1996
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Implementation of July 1998 Do Do
Section 126 of the Food and Drug
Administration Modernization Act of 1997--
Elimination of Certain Labeling Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Environmental Assessment July 1998 Do Do
of Human Drug and Biologics Applications
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53849]]
Guidance for Industry: Current Good September 1998 Do Do
Manufacturing Practice for Blood and Blood
Components: (1) Quarantine and Disposition of
Units From Prior Collections From Donors With
Repeatedly Reactive Screening Tests for
Antibody to Hepatitis C Virus (Anti-HCV); (2)
Supplemental Testing, and the Notification of
Consignees and Blood Recipients of Donor Test
Results for Anti-HCV
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Submitting September 1998 Do Do
Debarment Certification Statements
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: How to Complete the September 1998 Do Do
Vaccine Adverse Reporting System Form (VAERS-
1)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Fast Track Drug September 1998 Do Do
Development Programs--Designation,
Development, and Application Review
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Guidance on Statistical Principles for September 16, 1998 Do Do
Clinical Trials
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Guidance on Quality of Biotechnological/ September 21, 1998 Do Do
Biological Products: Derivation and
Characterization of Cell Substrates Used for
Production of Biotechnological/Biological
Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Guidance on Viral Safety Evaluation of September 24, 1998 Do Do
Biotechnology Products Derived From Cell Lines
of Human or Animal Origin
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: On Advisory Committees: October 1998 Do Do
Implementing Section 120 of the Food and Drug
Administration Act of 1997
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: General November 1998 Do Do
Considerations for Pediatric Pharmacokinetic
Studies for Drugs and Biological Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
To Viral Vaccine IND Sponsors--Use of PCR-Based December 18, 1998 Do Do
Reverse Transcriptase Assay
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: FDA Approval of New December 1998 Do Do
Cancer Treatment Uses for Marketed Drug and
Biological Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Content and Format December 1998 Do Do
of Geriatric Labeling
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Product Name January 1999 Do Do
Placement, Size and Prominence in Advertising
and Promotional Labeling
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Content and Format of January 1999 Do Do
Chemistry, Manufacturing and Controls
Information and Establishment Description
Information for a Vaccine or Related Product
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Amended Procedures for Advisory January 1999 Do Do
Panel Meetings
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53850]]
Guidance for Industry: Providing Regulatory January 1999 Do Do
Submissions in Electronic Format--General
Considerations
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: For the Submission of February 1999 Do Do
Chemistry, Manufacturing and Controls and
Establishment Description Information for
Human Plasma-Derived Biological Products,
Animal Plasma or Serum-Derived Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Population February 1999 Do Do
Pharmacokinetics
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Clinical Development February 1999 Do Do
Programs for Drugs, Devices and Biological
Products for the Treatment of Rheumatoid
Arthritis (RA)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: For the Submission of February 1999 Do Do
Chemistry, Manufacturing and Controls and
Establishment Description Information for
Human Plasma-Derived Biological Products,
Animal Plasma or Serum-Derived Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: INDs for Phase 2 February 1999 Do Do
and 3 Studies of Drugs, Including Specified
Therapeutic Biotechnology-Derived Products,
Chemistry, Manufacturing and Controls Content
and Format
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Accelerated March 1999 Do Do
Approval Products--Submission of Promotional
Materials
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Content and Format of March 1999 Do Do
Chemistry, Manufacturing and Controls
Information and Establishment Description
Information for a Biological In Vitro
Diagnostic Product
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Public Health Issues April 1999 Do Do
Posed by the Use of Nonhuman Primate
Xenografts in Humans
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry on the Content and Format April 1999 Do Do
of Chemistry, Manufacturing and Controls
Information and Establishment Description
Information for an Allergenic Extract or
Allergen Patch Test
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry for the Submission of May 1999 Do Do
Chemistry, Manufacturing and Controls and
Establishment Description Information for
Human Blood and Blood Components Intended for
Transfusion or for Further Manufacture and for
the Completion of the Form FDA 356h
``Application to Market a New Drug, Biologic
or an Antibiotic Drug for Human Use''
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry for Platelet Testing and May 1999 Do Do
Evaluation of Platelet Substitute Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Efficacy Studies to May 1999 Do Do
Support Marketing of Fibrin Sealant Products
Manufactured for Commercial Use
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53851]]
Guidance for Industry: Container Closure May 1999 Do Do
Systems for Packaging Human Drugs and
Biologics; Chemistry, Manufacturing, and
Controls Documentation
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Establishing June 1999 Do Do
Pregnancy Registries
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Reviewer Guidance: Evaluation of Human June 1999 FDA Personnel Do
Pregnancy Outcome Data
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Current Good June 1999 FDA Regulated Industry Do
Manufacturing Practice for Blood and Blood
Components: (1) Quarantine and Disposition of
Prior Collections From Donors With Repeatedly
Reactive Screening Tests for Hepatitis C Virus
(HCV); (2) Supplemental Testing, and the
Notification of Consignees and Transfusion
Recipients of Donor Test Results for Antibody
to HCV (Anti-HCV)
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Guidance on the Duration of Chronic June 25, 1999 Do Do
Toxicity Testing in Animals (Rodent and
Nonrodent Toxicity Testing)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Clinical July 1999 Do Do
Development Programs for Drugs, Devices, and
Biological Products Intended for the Treatment
of Osteoarthritis (OA)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Interpreting July 1999 Do Do
Sameness of Monoclonal Antibody Products Under
the Orphan Drug Regulations
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Cooperative August 1999 Do Do
Manufacturing Arrangements for Licensed
Biologics
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Consumer-Directed August 1999 Do Do
Broadcast Advertisements
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Information August 1999 Do Do
Request and Discipline Review Letters Under
the Prescription Drug User Fee Act
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Possible Dioxin/PCB August 1999 Do Do
Contamination of Drug and Biological Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Submission of August 1999 Do Do
Abbreviated Reports and Synopses in Support of
Marketing Applications
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Guidance on Specifications: Test Procedures August 18, 1999 Do Do
and Acceptance Criteria for Biotechnological/
Biological Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Revised September 1999 Do Do
Recommendations for the Invalidation of Test
Results When Using Licensed and 510(k) Cleared
Bloodborne Pathogen Assays to Test Donors
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Qualifying for Pediatric September 1999 Do Do
Exclusivity Under Section 505A of the Federal
Food, Drug, and Cosmetic Act
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53852]]
International Conference on Harmonisation Draft September 24, 1999 Do Do
Guidance; Choice of Control Group in Clinical
Trials
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Providing Regulatory November 1999 Do Do
Submissions to the Center for Biologics
Evaluation and Research (CBER) in Electronic
Format--Biologics Marketing Applications
[Biologics License Application (BLA), Product
License Application (PLA)/Establishment
License Application (ELA) and New Drug
Application (NDA)]--Revised
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Revised Precautionary November 1999 Do Do
Measures to Reduce the Possible Risk of
Transmission of Creutzfeldt-Jakob Disease
(CJD) and New Variant Creutzfeldt-Jakob
Disease (nvCJD) by Blood and Blood Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: In Vivo Drug Metabolism/ November 1999 Do Do
Drug Interaction Studies--Study Design, Data
Analysis and Recommendations for Dosing and
Labeling
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Application of November 1999 Do Do
Current Statutory Authority to Nucleic Acid
Testing of Pooled Plasma
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Pharmacokinetics November 1999 Do Do
in Patients With Impaired Hepatic Function:
Study Design, Data Analysis and Impact on
Dosing and Labeling
--------------------------------------------------------------------------------------------------------------------------------------------------------
International Conference on Harmonsation of November 8, 1999 Do Do
Technical Requirements for Registration of
Pharmaceuticals for Human Use M4: Common
Technical Document
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: In the Manufacture and December 1999 Do Do
Clinical Evaluation of In Vitro Tests to
Detect Nucleic Acid Sequences of Human
Immunodeficiency Viruses Types 1 and 2
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Precautionary December 1999 Do Do
Measures to Reduce the Possible Risk of
Transmission of Zoonoses by Blood and Blood
Products From Xenotransplantation Product
Recipients and Their Contacts
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Special Protocol December 1999 Do Do
Assessment
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Changes to an January 2000 Do Do
Approved Application: Biological Products:
Human Blood and Blood Components Intended for
Transfusion or for Further Manufacture
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Reviewers: Potency Limits February 2000 FDA Personnel Do
for Standardized Dust Mite and Grass Allergen
Vaccines: A Revised Protocol
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53853]]
Draft Guidance for Industry: IND Meetings for February 2000 FDA Regulated Industry Do
Human Drugs and Biologics: Chemistry,
Manufacturing, and Controls Information
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Formal Meetings With February 2000 Do Do
Sponsors and Applicants for PDUFA Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Formal Dispute February 2000 Do Do
Resolution: Appeals Above the Division Level
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Gamma Irradiation of February 2000 Do Do
Blood and Blood Components: A Pilot Program
for Licensing
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Information March 2000 Do Do
Program on Clinical Trials for Serious or Life-
Threatening Diseases: Establishment of a Data
Bank
--------------------------------------------------------------------------------------------------------------------------------------------------------
International Conference on Harmonisation; April 21, 2000 Do Do
Draft Revised Guidance on Q1A(R) Stability
Testing of New Drug Substances and Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Content and Format May 2000 Do Do
of the Adverse Reactions Section of Labeling
for Human Prescription Drugs and Biologics
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Recognition and Use of a June 2000 Do Do
Standard for the Uniform Labeling of Blood and
Blood Components
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Recommendations June 2000 Do Do
for Donor Questioning Regarding Possible
Exposure to Malaria
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Pediatric Oncology June 2000 Do Do
Studies in Response to a Written Request
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Availability of Licensed June 2000 Do Do
Donor Screening Tests Labeled for Use With
Cadaveric Blood Specimens (Level 2)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Chronic Cutaneous June 2000 Do Do
Ulcer and Burn Wounds--Developing Products for
Treatment
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: CBER Pilot June 2000 Do Do
Licensing Program for Immunization of Source
Plasma Donors Using Immunogen Red Blood Cells
Obtained From an Outside Supplier
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Developing Medical June 2000 Do Do
Imaging Drugs and Biological Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
International Conference on Harmonisation (ICH) June 2000 Do Do
Draft Guidance; Good Manufacturing Practice
Guide for Active Pharmaceutical Ingredients
(March 17, 2000)
--------------------------------------------------------------------------------------------------------------------------------------------------------
International Conference on Harmonisation (ICH) July 19, 2000 Do Do
Draft Revised Guidance on Impurities in New
Drug Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53854]]
International Conference on Harmonisation (ICH) July 20, 2000 Do Do
Draft Revised Guidance on Impurities in New
Drug Substances
--------------------------------------------------------------------------------------------------------------------------------------------------------
International Conference on Harmonisation (ICH) July 20, 2000 Do Do
Draft Guideline: Organisation of the Common
Technical Document for the Registration of
Pharmaceuticals for Human Use
--------------------------------------------------------------------------------------------------------------------------------------------------------
International Conference on Harmonisation (ICH) August 2000 Do Do
Draft Guideline on Safety Pharmacology Studies
for Human Pharmaceuticals
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Analytical August 2000 Do Do
Procedures and Methods Validation--Chemistry,
Manufacturing, and Controls Documentation
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Considerations for August 2000 Do Do
Reproductive Toxicity Studies for Preventive
Vaccines for Infectious Disease Indications
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Q & A Content and Format October 2000 Do Do
of INDs for Phase 1 Studies of Drugs,
Including Well-Characterized, Therapeutic,
Biotechnology-Derived Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Supplemental Guidance on October 2000 Do Do
Testing for Replication Competent Retrovirus
in Retroviral Vector Based Gene Therapy
Products and During Follow-up of Patients in
Clinical Trials Using Retroviral Vectors
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Submitting and Reviewing October 2000 Do Do
Complete Responses to Clinical Holds
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Cancer Drug and November 2000 Do Do
Biological Products--Clinical Data in
Marketing Applications
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Testing Limits in November 2000 Do Do
Stability Protocols for Standardized Grass
Pollen Extracts
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Use of Sterile November 2000 Do Do
Connecting Devices in Blood Bank Practices
(Level 2)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Recommendations November 2000 Do Do
for Complying With the Pediatric Rule (21 CFR
314.55(a) and 601.27(a))
--------------------------------------------------------------------------------------------------------------------------------------------------------
International Conference on Harmonisation (ICH) December 2000 Do Do
Guidance for Industry: E11 Clinical
Investigation of Medicinal Products in the
Pediatric Population
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Variances for December 2000 Do Do
Blood Collection From Individuals With
Hereditary Hemochromatosis
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53855]]
Draft Guidance for Industry: Submitting December 2000 Do Do
Separate Marketing Applications and Clinical
Data for Purposes of Assessing User Fees
--------------------------------------------------------------------------------------------------------------------------------------------------------
International Conference on Harmonisation; December 29, 2000 Do Do
Guidance on Q6A Specifications: Test
Procedures and Acceptance Criteria for New
Drug Substances and New Drug Products:
Chemical Substances
--------------------------------------------------------------------------------------------------------------------------------------------------------
PHS Guideline on Infectious Disease Issues in January 19, 2001 Do Do
Xenotransplantation
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Pre-Storage January 2001 Do Do
Leukocyte Reduction of Whole Blood and Blood
Components Intended for Transfusion
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Recommendations for January 2001 Do Do
Collecting Red Blood Cells by Automated
Apheresis Methods
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Providing January 2001 Do Do
Regulatory Submissions in Electronic Format--
Prescription Drug Advertising and Promotional
Labeling
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Source Animal, February 2001 Do Do
Product, Preclinical and Clinical Issues
Concerning the Use of Xenotransplantation
Products in Humans
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Recommendations for February 2001 Do Do
Collecting Red Blood Cells by Automated
Apheresis Methods--Technical Correction
February 2001
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Disclosing February 2001 Do Do
Information Provided to Advisory Committees in
Connection With Open Advisory Committee
Meetings Related to the Testing or Approval of
Biologic Products and Convened by the Center
for Biologics Evaluation and Research
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Postmarketing March 2001 Do Do
Safety Reporting for Human Drug and Biological
Products Including Vaccines
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Acceptance of Foreign March 2001 Do Do
Clinical Studies
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Financial Disclosure by March 2001 Do Do
Clinical Investigators
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Monoclonal Antibodies March 2001 Do Do
Used as Reagents in Drug Manufacturing
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Reports on the April 2001 Do Do
Status of Postmarketing Studies--
Implementation of Section 130 of the Food and
Drug Administration Modernization Act of 1997
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Using FDA-Approved April 2001 Do Do
Patient Labeling in Consumer-Directed Print
Advertisements
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53856]]
Draft Guidance for Industry: Forms for April 2001 Do Do
Registration of Producers of Drugs and Listing
of Drugs in Commercial Distribution
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Providing May 2001 Do Do
Regulatory Submissions in Electronic Format--
Postmarketing Expedited Safety Reports
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: E 10 Choice of Control May 2001 Do Do
Group and Related Issues in Clinical Trials
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: IND Meetings for May 2001 Do Do
Human Drugs and Biologics; Chemistry,
Manufacturing and Controls Information
--------------------------------------------------------------------------------------------------------------------------------------------------------
III. Guidance Documents Issued by the Center for Drug Evaluation and Research (CDER)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Intended User or Regulatory
Name of Document Date of Issuance Activity How to Obtain a Hard Copy of the Document
--------------------------------------------------------------------------------------------------------------------------------------------------------
Accelerated Approval Products--Submission of March 26, 1999 Advertising Draft http://www.fda.gov/cder/guidance/index.htm
Promotional Materials--Draft Division of Drug Information (HFD-200), Office
of Training and Communications, Center for
Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Product Name, Placement, Size, and Prominence March 12, 1999 Do Do
in Advertising and Promotional Labeling--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Promoting Medical Products in a Changing January 5, 1998 Do Do
Healthcare Environment; Medical Product
Promotion by Healthcare Organizations or
Pharmacy Management Companies--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Using FDA-Approved Patient Labeling in Consumer- April 23, 2001 Do Do
Directed Print Advertisements--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Aerosol Steroid Product Safety Information in January 12, 1998 Advertising Do
Prescription Drug Advertising and Promotional
Labeling
--------------------------------------------------------------------------------------------------------------------------------------------------------
Consumer-Directed Broadcast Advertisements August 9, 1999 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Industry-Supported Scientific and Educational December 3, 1997 Do Do
Activities
--------------------------------------------------------------------------------------------------------------------------------------------------------
Antifungal (Topical)--Draft February 24, 1990 Biopharmaceutic Draft Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Antifungal (Vaginal)--Draft February 24, 1990 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Bioavailability and Bioequivalence Studies for June 2, 1999 Do Do
Nasal Aerosols and Nasal Sprays for Local
Action--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Conjugated Estrogens, USP: LC-MS Method for March 9, 2000 Do Do
Both Qualitative Chemical Characterization and
Documentation of Qualitative Pharmaceutical
Equivalence--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53857]]
Food-Effect Bioavailability and Bioequivalence December 30, 1997 Do Do
Studies--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
In Vivo Bioequivalence Studies Based on December 10, 1997 Do Do
Population and Individual Bioequivalence
Studies--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Topical Dermatological Drug Product NDAs and June 18, 1998 Do Do
ANDAs--In Vivo Bioavailability,
Bioequivalence, In Vitro Release and
Associated Studies--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Bioanalytical Method Validation May 23, 2001 Biopharmaceutic Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Bioavailability and Bioequivalence Studies for October 27, 2000 Do Do
Orally Administered Drug Products--General
Considerations
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cholestyramine Powder In Vitro Bioequivalence July 15, 1993 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clozapine (Tablets) In Vivo Bioequivalence and November 15, 1996 Do Do
In Vitro Dissolution Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
Corticosteroids, Detmatologic (Topical) In Vivo June 2, 1995 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dissolution Testing of Immediate Release Solid August 25, 1997 Do Do
Oral Dosage Forms
--------------------------------------------------------------------------------------------------------------------------------------------------------
Extended Release Oral Dosage Forms: September 26, 1997 Do Do
Development, Evaluation, and Application of In
Vitro/In Vivo Correlations
--------------------------------------------------------------------------------------------------------------------------------------------------------
Levothyroxine Sodium Tablets--In Vivo March 8, 2001 Do Do
Pharmacokinetic and Bioavailability Studies
and In Vitro Dissolution Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
Metaproterenol Sulfate and Albuterol Metered June 27, 1989 Do Do
Dose Inhalers In Vitro
--------------------------------------------------------------------------------------------------------------------------------------------------------
Phenytoin/Phenytion Sodium (Capsules, Tablets, March 4, 1994 Do Do
Suspension) In Vivo Bioequivalence and In
Vitro Dissolution Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
Potassium Chloride (Slow-Release Tablets and June 6, 1994 Do Do
Capsules) In Vivo Bioequivalence and In Vitro
Dissolution Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
Statistical Approaches to Establishing February 2, 2001 Do Do
Bioequivalence
--------------------------------------------------------------------------------------------------------------------------------------------------------
Waiver of In Vivo Bioavailability and August 31, 2000 Do Do
Bioequivalence Studies for Immediate Release
Solid Oral Dosage Forms Based on a
Biopharmaceutics Classification System
--------------------------------------------------------------------------------------------------------------------------------------------------------
Analytical Procedures and Methods Validation: August 30, 2000 Chemistry Draft Do
Chemistry, Manufacturing, and Controls
Documentation--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Botanical Drug Products--Draft August 11, 2000 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
INDs for Phase 2 and 3 Studies of Drugs, April 20, 1999 Do Do
Including Specified Therapeutic Biotechnology-
Derived Products, Chemistry, Manufacturing,
and Controls Content and Format--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53858]]
Metered Dose Inhalers (MDI) and Dry Powder November 19, 1998 Do Do
Inhalers (DPI) Drug Products; Chemistry,
Manufacturing, and Controls Documentation--
Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Monoclonal Antibodies Used as Reagents in Drug June 24, 1999 Do Do
Manufacturing--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nasal Spray and Inhalation Solution, June 2, 1999 Do Do
Suspension, and Spray Drug Products--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Stability Testing of Drug Substances and Drug June 8, 1998 Do Do
Products--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submitting Supporting Chemistry Documentation November 1, 1991 Do Division of Drug Information (HFD-200), Office
in Radiopharmaceutical Drug Applications-- of Training and Communications, Center for
Draft Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
SUPAC-SS: Nonsterile Semisolid Dosage Forms January 5, 1999 Do http://www.fda.gov/cder/guidance/index.htm
Manufacturing Equipment Addendum--Draft Division of Drug Information (HFD-200), Office
of Training and Communications, Center for
Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tracking of NDA and NDA Reformulations for April 12, 1989 Do Division of Drug Information (HFD-200), Office
Solid, Oral, Immediate Release Drug Products-- of Training and Communications, Center for
Draft Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
BACPAC1: Intermediates in Drug Substance February 16, 2001 Chemistry Do
Synthesis: Bulk Actives Postapproval Changes:
Chemistry, Manufacturing, and Controls
Documentation
--------------------------------------------------------------------------------------------------------------------------------------------------------
Changes to an Approved Application for July 24, 1997 Do Do
Specified Biotechnology and Specified
Synthetic Biological Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Changes to an Approved NDA or ANDA November 23, 1999 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Changes to an Approved NDA or ANDA: Questions January 22, 2001 Do Do
and Answers
--------------------------------------------------------------------------------------------------------------------------------------------------------
Container Closure Systems for Packaging Human July 7, 1999 Do Do
Drugs and Biologics
--------------------------------------------------------------------------------------------------------------------------------------------------------
Development of New Stereoisomeric Drugs May 1, 1992 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Drug Master Files September 1, 1989 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Drug Master Files for Bulk Antibiotic Drug November 29, 1999 Do Do
Substances
--------------------------------------------------------------------------------------------------------------------------------------------------------
Environmental Assessment of Human Drugs and July 27, 1998 Do Do
Biologics Applications
--------------------------------------------------------------------------------------------------------------------------------------------------------
Format and Content for the CMC Section of an September 1, 1994 Do Do
Annual Report
--------------------------------------------------------------------------------------------------------------------------------------------------------
Format and Content of the Chemistry, February 1, 1987 Do Do
Manufacturing and Controls Section of an
Application
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53859]]
Format and Content of the Microbiology Section February 1, 1987 Do Do
of an Application
--------------------------------------------------------------------------------------------------------------------------------------------------------
IND Meetings for Human Drugs and Biologics; May 25, 2001 Do Do
Chemistry, Manufacturing, and Controls
Information
--------------------------------------------------------------------------------------------------------------------------------------------------------
Monoclonal Antibodies Used as Reagents in Drug March 29, 2001 Do Do
Manufacturing
--------------------------------------------------------------------------------------------------------------------------------------------------------
NDAs: Impurities in Drug Substances February 25, 2000 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
PAC-ALTS: Postapproval Changes--Analytical April 28, 1998 Do Do
Testing Laboratory Sites
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reviewer Guidance: Validation of November 1, 1994 Do Do
Chromatographic Methods
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submission of Chemistry, Manufacturing, and November 1, 1994 Do Do
Controls Information for Synthetic Peptide
Substances
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submission of Documentation for Sterilization November 1, 1994 Do Do
Process Validation Applications for Human and
Veterinary Drug Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submitting Documentation for the Manufacturing February 1, 1987 Do Do
of and Controls for Drug Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submitting Documentation for the Stability of February 1, 1987 Do Do
Human Drugs and Biologics
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submitting Samples and Analytical Data for February 1, 1987 Do Do
Methods Validation
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submitting Supporting Documentation in Drug February 1, 1987 Do Do
Applications for the Manufacture of Drug
Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submitting Supporting Documentation in Drug February 1, 1987 Do Do
Applications for the Manufacture of Drug
Substances
--------------------------------------------------------------------------------------------------------------------------------------------------------
SUPAC IR: Immediate-Release Solid Oral Dosage November 30, 1995 Do Do
Forms: Scale-Up and Post-Approval Changes:
Chemistry, Manufacturing, and Controls, In
Vitro Dissolution Testing and In Vivo
Bioequivalence Documentation
--------------------------------------------------------------------------------------------------------------------------------------------------------
SUPAC IR/MR: Immediate Release and Modified February 26, 1999 Do Do
Release Solid Oral Dosage Forms, Manufacturing
Equipment Addendum
--------------------------------------------------------------------------------------------------------------------------------------------------------
SUPAC-IR: Questions and Answers February 18, 1997 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
SUPAC-MR: Modified Release Solid Oral Dosage October 6, 1997 Do Do
Forms: Scale-Up and Postapproval Changes:
Chemistry, Manufacturing, and Controls, In
Vitro Dissolution Testing, and In Vivo
Bioequivalence Documentation
--------------------------------------------------------------------------------------------------------------------------------------------------------
SUPAC-SS: Nonsterile Semisolid Dosage Forms; June 13, 1997 Do Do
Scale-Up and Postapproval Changes: Chemistry,
Manufacturing, and Controls; In Vitro Release
Testing and In Vivo Bioequivalence
Documentation
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53860]]
The Sourcing and Processing of Gelatin to December 20, 2000 Do Do
Reduce the Potential Risk Posed by Bovine
Spongiform Encephalopathy
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acute Bacterial Exacerbation of Chronic July 22, 1998 Clinical Antimicrobial Do
Bronchitis; Developing Antimicrobial Drugs for Draft
Treatment--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acute Bacterial Meningitis; Developing July 22, 1998 Do Do
Antimicrobial Drugs for Treatment--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acute Bacterial Sinusitis; Developing July 22, 1998 Do Do
Antimicrobial Drugs for Treatment--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acute or Chronic Bacterial Prostatitis; July 22, 1998 Do Do
Developing Antimicrobial Drugs for Treatment--
Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acute Otitis Media; Developing Antimicrobial July 22, 1998 Do Do
Drugs for Treatment--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Bacterial Vaginosis; Developing Antimicrobial July 22, 1998 Do Do
Drugs for Treatment--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Catheter-Related Bloodstream Infections-- October 18, 1999 Do Do
Developing Antimicrobial Drugs for Treatment--
Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Considerations for Accelerated and September 1, 1999 Do Do
Traditional Approval of Antiretroviral Drugs
Using Plasma HIV RNA Measurements--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Community Acquired Pneumonia; Developing July 22, 1998 Do Do
Antimicrobial Drugs for Treatment--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Complicated Urinary Tract Infections and July 22, 1998 Do Do
Pylonephritis; Developing Antimicrobial Drugs
for Treatment--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Developing Antimicrobial Drugs--General July 22, 1998 Do Do
Considerations for Clinical Trials--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Empiric Therapy of Febrile Neutropenia; July 22, 1998 Do Do
Developing Antimicrobial Drugs for Treatment--
Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Evaluating Clinical Studies of Antimicrobials February 17, 1997 Do Do
in the Division of Anti-Infective Drug
Products--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Lyme Disease; Developing Antimicrobial Drugs July 22, 1998 Do Do
for Treatment--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nosocomial Pneumonia; Developing Antimicrobial July 22, 1998 Do Do
Drugs for Treatment--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Secondary Bacterial Infections of Acute July 22, 1998 Do Do
Bronchitis; Developing Antimicrobial Drugs for
Treatment--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Streptococcal Pharyngitis and Tonsillitis; July 22, 1998 Do Do
Developing Antimicrobial Drugs for Treatment--
Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Uncomplicated and Complicated Skin and Skin July 22, 1998 Do Do
Structure Infections; Developing Antimicrobial
Drugs for Treatment--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53861]]
Uncomplicated Gonorrhea--Cervical, Urethral, July 22, 1998 Do Do
Rectal, and/or Pharyngeal; Developing
Antimicrobial Drugs for Treatment--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Uncomplicated Urinary Tract Infections; July 22, 1998 Do Do
Developing Antimicrobial Drugs for Treatment--
Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Vulvovaginal Candidiasis; Developing July 22, 1998 Do Do
Antimicrobial Drugs for Treatment--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Development and Labeling of Anti- October 26, 1992 Clinical Antimicrobial Do
Infective Drug Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Anti-Infective Drugs September 1, 1977 Do Do
(Systemic)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Preclinical Development of Antiviral Drugs November 1, 1990 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Abuse Liability Assessment--Draft July 1, 1990 Clinical Medical Draft Division of Drug Information (HFD-200), Office
of Training and Communications, Center for
Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Allergic Rhinitis: Clinical Development June 21, 2000 Do http://www.fda.gov/cder/guidance/index.htm
Programs for Drug Products--Draft Division of Drug Information (HFD-200), Office
of Training and Communications, Center for
Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cancer Drug and Biological Products--Clinical November 9, 2000 Do Do
Data in Marketing Applications--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chronic Cutaneous Ulcer and Burn Wounds-- June 28, 2000 Do Do
Developing Products for Treatment--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Development Programs for Drugs, July 15, 1999 Do Do
Devices, and Biological Products Intended for
the Treatment of Osteoarthritis (OA)--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Anti-Anginal Drugs-- January 1, 1989 Do Division of Drug Information (HFD-200), Office
Draft of Training and Communications, Center for
Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Anti-Arrhythmic Drugs-- July 1, 1985 Do http://www.fda.gov/cder/guidance/index.htm
Draft Division of Drug Information (HFD-200), Office
of Training and Communications, Center for
Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Antihypertensive Drugs-- May 1, 1988 Do Do
Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53862]]
Clinical Evaluation of Drugs for the Treatment December 1, 1987 Do Division of Drug Information (HFD-200), Office
of Congestive Heart Failure--Draft of Training and Communications, Center for
Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Drugs for Ulcerative January 7, 1991 Do Do
Colitis (3rd draft)--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Lipid-Altering Agents In September 1, 1990 Do http://www.fda.gov/cder/guidance/index.htm
Adults and Children--Draft Division of Drug Information (HFD-200), Office
of Training and Communications, Center for
Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Motility-Modifying Date not available Do Division of Drug Information (HFD-200), Office
Drugs--Draft of Training and Communications, Center for
Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Weight-Control Drugs-- September 24, 1996 Do http://www.fda.gov/cder/guidance/index.htm
Draft Division of Drug Information (HFD-200), Office
of Training and Communications, Center for
Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Developing Medical Imaging Drugs and Biologics-- July 31, 2000 Do Do
Revised--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Development and Evaluation of Drugs for the February 12, 1992 Do Division of Drug Information (HFD-200), Office
Treatment of Psychoactive Substance Use of Training and Communications, Center for
Disorders--Draft Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Development of Parathyroid Hormones for the June 14, 2000 Do http://www.fda.gov/cder/guidance/index.htm
Prevention and Treatment of Osteoporosis-- Division of Drug Information (HFD-200), Office
Draft of Training and Communications, Center for
Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Establishing Pregnancy Registries--Draft June 4, 1999 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Evaluation of Human Pregnancy Outcome Data-- June 4, 1999 Do Do
Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Female Sexual Dysfunction: Clinical Development May 19, 2000 Do Do
of Drug Products for Treatment--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Institutional Review Boards, Clinical March 30, 2000 Do Do
Investigators, and Sponsors: Exception From
Informed Consent Requirements for Emergency
Research--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
OTC Treatment of Herpes Labialis With Antiviral March 8, 2000 Do Do
Agents--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pediatric Oncology Studies in Response to a June 21, 2000 Do Do
Written Request--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53863]]
Postmarketing Safety Reporting for Human Drug March 12, 2001 Do Do
and Biological Products Including Vaccines--
Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Preclinical and Clinical Evaluation of Agents April 1, 1994 Do Do
Used in the Prevention or Treatment of
Postmenopausal Osteoporosis--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Preparation of IND Applications for New Drugs September 1, 1991 Do Division of Drug Information (HFD-200), Office
Intended for the Treatment of HIV-Infected of Training and Communications, Center for
Individuals--Draft Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recommendations for Complying With the December 4, 2000 Do http://www.fda.gov/cder/guidance/index.htm
Pediatric Rule--Draft Division of Drug Information (HFD-200), Office
of Training and Communications, Center for
Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
System Inflammatory Response Syndrome (SIRS) July 1993 Do Division of Drug Information (HFD-200), Office
(1st draft)--Draft of Training and Communications, Center for
Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acceptance of Foreign Clinical Studies March 13, 2001 Clinical Medical http://www.fda.gov/cder/guidance/index.htm
Division of Drug Information (HFD-200), Office
of Training and Communications, Center for
Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Development Programs for Drugs, February 17, 1999 Do Do
Devices, and Biological Products for the
Treatment of Rheumatoid Arthritis (RA)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Development Programs for MDI and DPI September 19, 1994 Do Do
Drug Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Analgesic Drugs December 1, 1992 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Antacid Drugs April 1, 1978 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Anti-Inflammatory and April 1, 1988 Do Do
Antirheumatic Drugs (Adults and Children)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Antianxiety Drugs September 1, 1977 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Antidepressant Drugs September 1, 1977 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Antidiarrheal Drugs September 1, 1977 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Antiepileptic Drugs January 1, 1981 Do Do
(Adults and Children)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Combination Estrogen/ March 20, 1995 Do Do
Progestin-Containing Drug Products Used for
Hormone Replacement Therapy of Postmenopausal
Women
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Gastric Secretory September 1, 1977 Do Do
Depressant (GSD) Drugs
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53864]]
Clinical Evaluation of General Anesthetics May 1, 1982 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Hypnotic Drugs September 1, 1977 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Laxative Drugs April 1, 1978 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Local Anesthetics May 1, 1982 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Psychoactive Drugs in July 1, 1979 Do Do
Infants and Children
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Radiopharmaceutical October 1, 1981 Do Do
Drugs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Content and Format for Pediatric Use May 24, 1996 Do Do
Supplements
--------------------------------------------------------------------------------------------------------------------------------------------------------
Content and Format of Investigational New Drug November 20, 1995 Do Do
Applications (INDs) for Phase 1 Studies of
Drugs, Including Well-Characterized,
Therapeutic, Biotechnology-Derived Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Development of Vaginal Contraceptive Drugs April 19, 1995 Do Do
(NDA)
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDA Approval of New Cancer Treatment Uses for February 2, 1999 Do Do
Marketed Drug and Biological Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDA Requirements for Approval of Drugs to Treat January 29, 1991 Do Do
Non-Small Lung Cancer
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDA Requirements for Approval of Drugs to Treat June 20, 1989 Do Do
Superficial Bladder Cancer
--------------------------------------------------------------------------------------------------------------------------------------------------------
Format and Content of the Clinical and July 1, 1988 Do Do
Statistical Sections of an Application
--------------------------------------------------------------------------------------------------------------------------------------------------------
Format and Content of the Summary for New Drug February 1, 1987 Do Do
and Antibiotic Applications
--------------------------------------------------------------------------------------------------------------------------------------------------------
Formatting, Assembling and Submitting New Drug February 1, 1987 Do Do
and Antibiotic Applications
--------------------------------------------------------------------------------------------------------------------------------------------------------
General Considerations for the Clinical December 1, 1978 Do Do
Evaluation of Drugs
--------------------------------------------------------------------------------------------------------------------------------------------------------
General Considerations for the Clinical September 1, 1977 Do Do
Evaluation of Drugs in Infants and Children
--------------------------------------------------------------------------------------------------------------------------------------------------------
Levothyroxine Sodium Tablets--In Vivo March 8, 2001 Do Do
Pharmacokinetic and Bioavailability Studies
and In Vitro Dissolution Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
Oncologic Drugs Advisory Committee Discussion April 13, 1988 Do Do
on FDA Requirements for Approval of New Drugs
for Treatment of Ovarian Cancer
--------------------------------------------------------------------------------------------------------------------------------------------------------
Oncologic Drugs Advisory Committee Discussion April 19, 1988 Do Do
on FDA Requirements for Approval of New Drugs
for Treatment of Colon and Rectal Cancer
--------------------------------------------------------------------------------------------------------------------------------------------------------
Postmarketing Adverse Experience Reporting for August 27, 1997 Do Do
Human Drug and Licensed Biological Products;
Clarification of What to Report
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53865]]
Postmarketing Reporting of Adverse Drug March 1, 1992 Do Do
Experiences
--------------------------------------------------------------------------------------------------------------------------------------------------------
Preclinical Development of Immunomodulatory September 4, 1992 Do Do
Drugs for the Treatment of HIV Infection and
Associated Disorders
--------------------------------------------------------------------------------------------------------------------------------------------------------
Preparation of Investigational New Drug November 1, 1992 Do Do
Products (Human and Animal)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Providing Clinical Evidence of Effectiveness May 15, 1998 Do Do
for Human Drug and Biological Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Study and Evaluation of Gender Differences in July 22, 1993 Do Do
the Clinical Evaluation of Drugs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Study of Drugs Likely To Be Used in the Elderly November 1, 1989 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submission of Abbreviated Reports and Synopses September 13, 1999 Do Do
in Support of Marketing Applications
--------------------------------------------------------------------------------------------------------------------------------------------------------
General Considerations for Pediatric November 30, 1998 Clinical Pharmacology Draft Do
Pharmacokinetic Studies for Drugs and
Biological Products--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pharmacokinetics in Patients With Impaired December 7, 1999 Do Do
Hepatic Function: Study Design, Data Analysis,
and Impact on Dosing and Labeling--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Drug Metabolism/Drug Interaction Studies in the April 7, 1997 Clinical Pharmacology Do
Drug Development Process: Studies In Vitro
--------------------------------------------------------------------------------------------------------------------------------------------------------
Format and Content of the Human February 1, 1987 Do Do
Pharmacokinetics and Bioavailability Section
of an Application
--------------------------------------------------------------------------------------------------------------------------------------------------------
In Vivo Metabolism/Drug Interaction Studies-- November 24, 1999 Do Do
Study Design, Data Analysis, and
Recommendations for Dosing and Labeling
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pharmacokinetics and Pharmacodynamics in May 15, 1998 Do Do
Patients With Impaired Renal Function: Study
Design, Data Analysis, and Impact on Dosing
and Labeling
--------------------------------------------------------------------------------------------------------------------------------------------------------
Population Pharmacokinetics February 10, 1999 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for IRBs, Clinical Investigators, and March 30, 2000 Compliance Draft Do
Sponsors: Exception from Informed Consent
Requirements for Emergency Research (21 CFR
50.24)--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Investigating Out of Specification (OOS) Test September 30, 1998 Do Do
Results for Pharmaceutical Production--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Manufacture, Processing or Holding of Active April 17, 1998 Do Do
Pharmaceutical Ingredients--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Repacking of Solid Oral Dosage Form Drug February 1, 1992 Do Do
Products--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53866]]
A Review of FDA's Implementation of the Drug Compliance Do
Export Amendments of 1986
--------------------------------------------------------------------------------------------------------------------------------------------------------
Compressed Medical Gases December 1, 1989 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Computerized Systems Used in Clinical Trials May 10, 1999 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Expiration Dating and Stability Testing of June 27, 1997 Do Do
Solid Oral Dosage Form Drugs Containing Iron
--------------------------------------------------------------------------------------------------------------------------------------------------------
General Principles of Process Validation May 1, 1987 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Good Laboratory Practice Regulations Questions Do Do
and Answers
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Hospitals, Nursing Homes, and April 6, 2001 Do Do
Other Health Care Facilities
--------------------------------------------------------------------------------------------------------------------------------------------------------
Monitoring of Clinical Investigations January 1, 1988 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nuclear Pharmacy Guideline Criteria for May 1, 1984 Do Do
Determining When to Register as a Drug
Establishment
--------------------------------------------------------------------------------------------------------------------------------------------------------
Possible Dioxin/PCB Contamination of Drug and August 23, 1999 Do Do
Biological Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sterile Drug Products Produced by Aseptic May 1, 1987 Do Do
Processing
--------------------------------------------------------------------------------------------------------------------------------------------------------
Street Drug Alternatives April 3, 2000 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Validation of Limulus Amebocyte Lysate Test as December 1, 1987 Do Do
an End-Product Endotoxin Test for Human and
Animal Parenteral Drugs, Biological Products,
and Medical Devices
--------------------------------------------------------------------------------------------------------------------------------------------------------
Providing Regulatory Submissions in Electronic May 4, 2001 Electronic Submission Draft Do
Format--Postmarketing Expedited Safety
Reports--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Providing Regulatory Submissions in Electronic January 31, 2001 Do Do
Format: Prescription Drug Advertising and
Promotional Labeling--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Preparing Data for Electronic Submissions in September 23, 1999 Electronic Submission Do
ANDAs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulatory Submissions in Electronic Format; January 28, 1999 Do Do
General Considerations
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulatory Submissions in Electronic Format; January 28, 1999 Do Do
New Drug Applications
--------------------------------------------------------------------------------------------------------------------------------------------------------
ANDAs; Blend Uniformity Analysis--Draft August 26, 1999 Generic Drug Draft Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
ANDAs; Impurities in Drug Products--Draft January 5, 1999 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Content and Format of an Abbreviated New Drug April 18, 1997 Do Do
Application (ANDA)--Positron Emission
Tomography (PET) Drug Products--With Specific
Information for ANDAs for Fludeoxyglucose F18
Injection--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Alternate Source of Active Pharmaceutical December 12, 2000 Do Do
Ingredients in Pending ANDAs--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53867]]
ANDAs: Impurities in Drug Substances December 3, 1999 Generic Drugs Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Court Decisions, ANDA Approvals, and 180-Day March 30, 2000 Do Do
Exclusivity Under the Hatch-Waxman Amendments
to the Federal Food, Drug, and Cosmetic Act
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter Announcing That the OGD Will Now Accept August 18, 1995 Do Do
the ICH Long-Term Storage Conditions as Well
as the Stability Studies Conducted in the Past
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter Describing Efforts by CDER and ORA to October 14, 1994 Do Do
Clarify the Responsibilities of CDER Chemistry
Review Scientists and ORA Field Investigators
in the New and Abbreviated Drug Approval
Process in Order to Reduce Duplication or
Redundancy in the Process
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter on Incomplete Abbreviated Applications, April 8, 1994 Do Do
Convictions Under GDEA, Multiple Supplements,
Annual Reports for Bulk Antibiotics, Batch
Size for Transdermal Drugs, Bioequivalence
Protocols, Research, Deviations From OGD
Policy
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter on the Provision of New Information July 1, 1992 Do Do
Pertaining to New Bioequivalence Guidelines
and Refuse-to-File Letters
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter on the Provision of New Procedures and March 15, 1989 Do Do
Policies Affecting the Generic Drug Review
Process
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter on the Request for Cooperation of November 8, 1991 Do Do
Regulated Industry to Improve the Efficiency
and Effectiveness of the Generic Drug Review
Process, by Assuring the Completeness and
Accuracy of Required Information and Data
Submissions
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter on the Response to 12/20/84 Letter From March 26, 1985 Do Do
the Pharmaceutical Manufacturers Association
About the Drug Price Competition and Patent
Term Restoration Act
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter to all ANDA and AADA Applicants About January 15, 1993 Do Do
the Generic Drug Enforcement Act of 1992
(GDEA), and the Office of Generic Drugs
intention to Refuse-to-File Incomplete
Submissions as Required by the New Law
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter to Regulated Industry Notifying August 4, 1993 Do Do
Interested Parties About Important Detailed
Information Regarding Labeling, Scale-up,
Packaging, Minor/major Amendment Criteria, and
Bioequivalence Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
Major, Minor, Facsimile, and Telephone May 1, 2000 Do Do
Amendments to Original Abbreviated New Drug
Applications (Revised)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Organization of an ANDA March 2, 1999 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Revising ANDA Labeling Following Revision of April 25, 2000 Do Do
the RLD Labeling
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53868]]
Skin Irritation and Sensitization Testing of February 3, 2000 Do Do
Generic Transdermal Drug Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Variations in Drug Products That May Be January 27, 1999 Do Do
Included ANDA
--------------------------------------------------------------------------------------------------------------------------------------------------------
Conducting a Clinical Safety Review of a New November 22, 1996 Good Review Practices Draft Do
Product Application and Preparing a Report on
the Review--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pharmacology/Toxicology Review Format May 10, 2001 Good Review Practices Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Q1A(R)--Stability Testing of New Drug April 21, 2000 ICH Draft--Quality Do
Substances and Products--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Q3A(R)--Impurities in New Drug Substances-- July 20, 2000 Do Do
Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Q3B(R)--Impurities in New Drug Products--Draft July 19, 2000 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Q6A--Specifications: Test Procedures and November 25, 1997 Do Do
Acceptance Criteria for New Drug Substances
and New Drug Products: Chemical Substances--
Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Q7A--Good Manufacturing Practice for Active August 1, 2000 Do Do
Pharmaceutical Ingredients--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
S7--Safety Pharmacology Studies for Human August 7, 2000 ICH Draft--Safety Do
Pharmaceuticals--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
E12 A--Principles for Clinical Evaluation of August 9, 2000 ICH Draft--Efficacy Do
New Antihypertensive Drugs--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
M4--Common Technical Document--Draft August 24, 2000 ICH Draft--Joint Safety/ Do
Efficacy
(Multidisciplinary)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Q1A--Stability Testing of New Drug Substances September 22, 1994 ICH--Quality Do
and Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
QIB--Photostability Testing of New Drug May 16, 1997 Do Do
Substances and Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
QIC--Stability Testing for New Dosage Forms May 9, 1997 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Q2A--Text on Validation of Analytical March 1, 1995 Do Do
Procedures
--------------------------------------------------------------------------------------------------------------------------------------------------------
Q2B--Validation of Analytical Procedures: May 19, 1997 Do Do
Methodology
--------------------------------------------------------------------------------------------------------------------------------------------------------
Q3A--Impurities in New Drug Substances January 4, 1996 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Q3B(R)-- Impurities in New Drug Products July 19, 2000 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Q3C--Impurities: Residual Solvents December 24, 1997 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Q5A--Viral Safety Evaluation of Biotechnology September 24, 1998 Do Do
Products Derived From Cell Lines of Human or
Animal Origin
--------------------------------------------------------------------------------------------------------------------------------------------------------
Q5B--Quality of Biotechnology Products: February 23, 1996 Do Do
Analysis of the Expression Construct in Cells
Used for Production of r-DNA Derived Protein
Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53869]]
Q5C--Quality of Biotechnological Products: July 10, 1996 Do Do
Stability Testing of Biotechnology/Biological
Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Q5D--Quality of Biotechnological/Biological September 21, 1998 Do Do
Products: Derivation and Characterization of
Cell Substrates Used for Production of
Biotechnological/Biological Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Q6A--Specifications: Test Procedures and December 29, 2000 Do Do
Acceptance Criteria for New Drug Substances
and New Drug Products: Chemical Substances
--------------------------------------------------------------------------------------------------------------------------------------------------------
Q6B--Test Procedures and Acceptance Criteria August 18, 1999 Do Do
for Biotechnological/Biological Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
S1A--The Need for Long-Term Rodent March 1, 1996 ICH--Safety Do
Carcinogenicity Studies of Pharmaceuticals
--------------------------------------------------------------------------------------------------------------------------------------------------------
S1B--Testing for Carcinogenicity in February 23, 1998 Do Do
Pharmaceuticals
--------------------------------------------------------------------------------------------------------------------------------------------------------
S1C--Dose Selection for Carcinogenicity Studies March 1, 1995 Do Do
of Pharmaceuticals
--------------------------------------------------------------------------------------------------------------------------------------------------------
S1C(R)--Dose Selection for Carcinogenicity December 4, 1997 Do Do
Studies of Pharmaceuticals: Addendum on a
Limit Dose and Related Notes
--------------------------------------------------------------------------------------------------------------------------------------------------------
S2A--Specific Aspects of Regulatory April 24, 1996 Do Do
Genotoxicity Tests for Pharmaceuticals
--------------------------------------------------------------------------------------------------------------------------------------------------------
S2B--Genotoxicity: Standard Battery Testing November 21, 1997 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
S3A--Toxicokinetics: The Assessment of Systemic March 1, 1995 Do Do
Exposure in Toxicity Studies
--------------------------------------------------------------------------------------------------------------------------------------------------------
S3B--Pharmacokinetics: Guidance for Repeated March 1, 1995 Do Do
Dose Tissue Distribution Studies
--------------------------------------------------------------------------------------------------------------------------------------------------------
S4A--Duration of Chronic Toxicity Testing in June 25, 1999 Do Do
Animals (Rodent and Nonrodent Toxicity
Testing)
--------------------------------------------------------------------------------------------------------------------------------------------------------
S5A--Detection of Toxicity to Reproduction for September 22, 1994 Do Do
Medicinal Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
S5B--Detection of Toxicity to Reproduction for April 5, 1996 Do Do
Medicinal Products: Addendum on Toxicity to
Male Fertility
--------------------------------------------------------------------------------------------------------------------------------------------------------
S6--Preclinical Safety Evaluation of November 18, 1997 Do Do
Biotechnology-Derived Pharmaceuticals
--------------------------------------------------------------------------------------------------------------------------------------------------------
S7A--Safety Pharmacology Studies for Human July 13, 2001 Do Do
Pharmaceuticals
--------------------------------------------------------------------------------------------------------------------------------------------------------
EIA--The Extent of Population Exposure to March 1, 1995 ICH--Efficacy Do
Assess Clinical Safety: for Drugs Intended for
Long-Term Treatment of Non-Life-Threatening
Conditions
--------------------------------------------------------------------------------------------------------------------------------------------------------
E2A--Clinical Safety Data Management: March 1, 1995 Do Do
Definitions and Standards for Expedited
Reporting
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53870]]
E2B--Data Elements for Transmission of January 15, 1998 Do Do
Individual Case Safety Reports
--------------------------------------------------------------------------------------------------------------------------------------------------------
E2C--Clinical Safety Data Management: Periodic May 19, 1997 Do Do
Safety Update Reports for Marketed Drugs
--------------------------------------------------------------------------------------------------------------------------------------------------------
E3--Structure and Content of Clinical Study July 17, 1996 Do Do
Reports
--------------------------------------------------------------------------------------------------------------------------------------------------------
E4--Dose-Response Information to Support Drug November 9, 1994 Do Do
Registration
--------------------------------------------------------------------------------------------------------------------------------------------------------
E5--Ethnic Factors in the Acceptability of June 10, 1998 Do Do
Foreign Clinical Data
--------------------------------------------------------------------------------------------------------------------------------------------------------
E6--Good Clinical Practice: Consolidated May 9, 1997 Do Do
Guideline
--------------------------------------------------------------------------------------------------------------------------------------------------------
E7--Studies in Support of Special Populations: August 2, 1994 Do Do
Geriatrics
--------------------------------------------------------------------------------------------------------------------------------------------------------
E8--General Considerations for Clinical Trials December 24, 1997 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
E9--Statistical Principles for Clinical Trials September 16, 1998 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
E10--International Conference on Harmonisation: May 14, 2001 Do Do
Choice of Control Group and Related Issues in
Clinical Trials
--------------------------------------------------------------------------------------------------------------------------------------------------------
E11--Clinical Investigation of Medicinal December 15, 2000 Do Do
Products in the Pediatric Population
--------------------------------------------------------------------------------------------------------------------------------------------------------
M3--Nonclinical Safety Studies for the Conduct November 25, 1997 ICH--Joint Safety/Efficacy Do
of Human Clinical Trials for Pharmaceuticals (Multidisciplinary)
--------------------------------------------------------------------------------------------------------------------------------------------------------
A Revision in Sample Collection Under the July 15, 1996 Industry Letters Division of Drug Information (HFD-200), Office
Compliance Program Pertaining to Pre-Approval of Training and Communications, Center for
Inspections Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Certification Requirements for Debarred June 1, 1990 Do Do
Individuals in Drug Applications
--------------------------------------------------------------------------------------------------------------------------------------------------------
Continuation of a Series of Letters March 2, 1998 Do Http://www.fda.gov/cder/guidance/index.htm
Communicating Interim and Informal Generic Division of Drug Information (HFD-200), Office
Drug Policy and Guidance. Availability of of Training and Communications, Center for
Policy and Procedure Guides, and Further Drug Evaluation and Research, Food and Drug
Operational Changes to the Generic Drug Review Administration, 5600 Fishers Lane, Rockville,
Program MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fifth of a Series of Letters Providing Informal April 10, 1987 Do Do
Notice About the Act, Discussing the Statutory
Mechanism by Which ANDA Applicants May Make
Modifications in Approved Drugs Where Clinical
Data Is Required
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fourth of a Series of Letters Providing October 31, 1986 Do Do
Informal Notice to Affected Parties About
Policy Developments and Interpretations
Regarding the Act. Three-Year Exclusivity
Provisions of Title 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53871]]
Implementation of the Drug Price Competition October 11, 1984 Do Do
and Patent Term Restoration Act; Preliminary
Guidance
--------------------------------------------------------------------------------------------------------------------------------------------------------
Implementation Plan USP Injection Nomenclature October 2, 1995 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Instructions for Filing Supplements Under the April 11, 1996 Do Division of Drug Information (HFD-200), Office
Provisions of SUPAC-IR of Training and Communications, Center for
Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Seventh of a Series of Letters About the Act July 29, 1988 Do Http://www.fda.gov/cder/guidance/index.htm
Providing Guidance on the ``180-Day Division of Drug Information (HFD-200), Office
Exclusivity'' Provision of Section of Training and Communications, Center for
505(j)(4)(B)(iv) of the Act Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sixth of a Series of Informal Notice Letters April 28, 1988 Do Do
About the Act Discussing 3- and 5-year
Exclusivity Provisions of Section 505(c)(3)(D)
and (j)(4)(D) of the Act
--------------------------------------------------------------------------------------------------------------------------------------------------------
Streamlining Initiative December 24, 1996 Do Division of Drug Information (HFD-200), Office
of Training and Communications, Center for
Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Supplement to 10/11/84 Letter About Policies, November 16, 1984 Do http://www.fda.gov/cder/guidance/index.htm
Procedures and Implementation of the Act (Q & Division of Drug Information (HFD-200), Office
A Format) of Training and Communications, Center for
Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Third of a Series of Letters Regarding the May 1, 1985 Do Do
Implementation of the Act
--------------------------------------------------------------------------------------------------------------------------------------------------------
Y2K Letter From Dr. Janet Woodcock October 19, 1998 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Combined Oral Contraceptives--Labeling for July 10, 2000 Labeling Draft Do
Healthcare Providers and Patients--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Content and Format for Geriatric Labeling-- January 21, 1999 Do Do
Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Content and Format of the Adverse Reactions June 21, 2000 Do Do
Section of Labeling for Human Prescription
Drugs and Biologics--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Non-Contraceptive Estrogen Drug Products-- January 8, 1999 Do Do
Physician and Patient Labeling--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Noncontraceptive Estrogen Class Labeling--Draft September 27, 1999 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Labeling of OTC Topical Drug Products for the July 16, 1998 Do Do
Treatment of Vaginal Yeast Infections
(Vulvovaginal Candidiasis)--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53872]]
Referencing Discontinued Labeling for Listed October 26, 2000 Do Do
Drugs in Abbreviated New Drug Applications--
Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Therapeutic Equivalence Code Placement on January 28, 1999 Do Do
Prescription Drug Labels and Labeling--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acetaminophen and Codeine Phosphate Tablets/ December 1, 1993 Labeling Do
Capsules
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acetaminophen and Codeine Phosphate Oral December 1, 1993 Do Do
Solution/Suspension
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acetaminophen, Aspirin and Codeine Phosphate December 1, 1993 Do Do
Tablets/Capsules
--------------------------------------------------------------------------------------------------------------------------------------------------------
Alprazolam Tablets USP August 1, 1996 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Amiloride Hydrochloride and Hydrochlorothiazide September 1, 1997 Do Do
Tablets USP
--------------------------------------------------------------------------------------------------------------------------------------------------------
Amlodipine Besylate Tablets September 1, 1997 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Astemizole Tablets September 1, 1997 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Atenolol Tablets USP August 1, 1997 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Barbiturate, Single Entity-Class Labeling March 1, 1981 Do Division of Drug Information (HFD-200), Office
of Training and Communications, Center for
Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Butalbital, Acetaminophen and Caffeine Capsules/ September 1, 1997 Do http://www.fda.gov/cder/guidance/index.htm
Tablets USP Division of Drug Information (HFD-200), Office
of Training and Communications, Center for
Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Butalbital, Acetaminophen, Caffeine and September 21, 1997 Do Do
Hydocodone Bitartrate Tablets
--------------------------------------------------------------------------------------------------------------------------------------------------------
Butorphanol Tartrate Injection USP October 1, 1992 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Captopril and Hydrochlorothiazide Tablets USP April 1, 1995 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Captopril Tablets February 1, 1995 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Carbidopa and Levodopa Tablets USP February 1, 1992 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chlordiazepoxide Hydrochloride Capsules January 1, 1988 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cimetidine Hydrochloride Injection September 1, 1995 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cimetidine Tablets September 1, 1995 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cisapride Oral Suspension September 1, 1997 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cisapride Tablets September 1, 1997 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clindamycin Phosphate Injection USP September 1, 1998 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53873]]
Clorazepate Dipotassium Capsules/Tablets March 1, 1993 Do Division of Drug Information (HFD-200), Office
of Training and Communications, Center for
Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Combination Oral Contraceptives--Physician and January 1, 1994 Do Do
Patient Labeling
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cyproheptadine Hydrochloride Tablets/Syrup December 1, 1986 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Diclofenac Sodium Delayed-Release Tablets January 1, 1997 Do http://www.fda.gov/cder/guidance/index.htm
Division of Drug Information (HFD-200), Office
of Training and Communications, Center for
Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Diltiazem Hydrochloride Extended-Release September 1, 1995 Do Do
Capsules
--------------------------------------------------------------------------------------------------------------------------------------------------------
Diphenoxylate Hydrochloride and Atropine April 1, 1995 Do Do
Sulfate Oral Solution USP
--------------------------------------------------------------------------------------------------------------------------------------------------------
Diphenoxylate Hydrochloride and Atropine April 1, 1995 Do Do
Sulfate Tablets USP
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dipivefrin Hydrochloride Ophthalmic Solution, November 2, 1998 Do Division of Drug Information (HFD-200), Office
0.1% of Training and Communications, Center for
Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Ergoloid Mesylates Tablets January 1, 1988 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fludeoxyglucose F18 Injection January 1, 1997 Do http://www.fda.gov/cder/guidance/index.htm
Division of Drug Information (HFD-200), Office
of Training and Communications, Center for
Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Flurbiprofen Tablets USP January 1, 1994 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fluvoxamine Maleate Tablets September 1, 1997 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Gentamicin Sulfate Ophthalmic Ointment and April 1, 1992 Do Do
Solution USP
--------------------------------------------------------------------------------------------------------------------------------------------------------
Heparin Sodium Injection USP March 1, 1991 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Hydrocodone Bitartrate and Acetaminophen April 1, 1994 Do Do
Tablets USP
--------------------------------------------------------------------------------------------------------------------------------------------------------
Hydroxyzine Hydrochloride Injection December 1, 1989 Do Division of Drug Information (HFD-200), Office
of Training and Communications, Center for
Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Hypoglycemic Oral Agents Federal Register April 1, 1984 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53874]]
Indomethacin Capsules USP September 1, 1995 Do http://www.fda.gov/cder/guidance/index.htm
Division of Drug Information (HFD-200), Office
of Training and Communications, Center for
Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Informal Labeling Guidance Texts for Estrogen August 1, 1992 Do Division of Drug Information (HFD-200), Office
Drug Products Patient Labeling of Training and Communications, Center for
Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Informal Labeling Guidance Texts for Estrogen August 1, 1992 Do Do
Drug Products: Professional Labeling
--------------------------------------------------------------------------------------------------------------------------------------------------------
Isoetharine Inhalation Solution March 1, 1989 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Itraconazole Capsules, USP September 1, 1998 Do http://www.fda.gov/cder/guidance/index.htm
Division of Drug Information (HFD-200), Office
of Training and Communications, Center for
Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Leucovorin Calcium for Injection July 1, 1996 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Leucovorin Calcium Tablets, USP July 1, 1996 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Local Anesthetics Class Labeling September 1, 1982 Do Division of Drug Information (HFD-200), Office
of Training and Communications, Center for
Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Meclofenamate Sodium Capsules July 1, 1992 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medroxyprogesterone Acetate Tablets, USP September 1, 1998 Do http://www.fda.gov/cder/guidance/index.htm
Division of Drug Information (HFD-200), Office
of Training and Communications, Center for
Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Metaproterenol Sulfate Inhalation Solution USP May 1, 1992 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Metaproterenol Sulfate Syrup USP May 1, 1992 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Metaproterenol Sulfate Tablets May 1, 1992 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Metoclopramide Tablets USP/Oral Solution February 1, 1995 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Naphazoline Hydrochloride Ophthalmic Solution March 1, 1989 Do Division of Drug Information (HFD-200), Office
of Training and Communications, Center for
Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53875]]
Naproxen Sodium Tablets, USP September 1, 1997 Do http://www.fda.gov/cder/guidance/index.htm
Division of Drug Information (HFD-200), Office
of Training and Communications, Center for
Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Naproxen Tablets, USP September 1, 1997 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Niacin Tablets July 1, 1982 Do Division of Drug Information (HFD-200), Office
of Training and Communications, Center for
Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Paclitaxel Injection September 1, 1997 Do http://www.fda.gov/cder/guidance/index.htm
Division of Drug Information (HFD-200), Office
of Training and Communications, Center for
Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Phendimetrazine Tartrate Capsules/T Nets, and February 1, 1991 Do Division of Drug Information (HFD-200), Office
Extended-Release Capsules of Training and Communications, Center for
Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Phentermine Hydrochloride Capsules/Tablets August 1, 1988 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Promethazine Hydrochloride Tablets March 1, 1990 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Propantheline Bromide Tablets August 1, 1988 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pyridoxine Hydrochloride Injection June 1, 1984 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Quinidine Sulfate Tablets/Capsules USP October 1, 1995 Do http://www.fda.gov/cder/guidance/index.htm
Division of Drug Information (HFD-200), Office
of Training and Communications, Center for
Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Ranitidine Tablets USP November 1, 1993 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Risperidone Oral Solution September 1, 1997 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Risperidone Tablets September 1, 1997 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sulfacetainide Sodium and Prednisolone Acetate January 1, 1995 Do Do
Ophthalmic Suspension and Ointment
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sulfacetamide Sodium Ophthalmic Solution/ August 1, 1992 Do Do
Ointment
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sulfamethoxazole and Phenazopyridine February 1, 1992 Do Division of Drug Information (HFD-200), Office
Hydrochloride Tablets of Training and Communications, Center for
Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53876]]
Sulfamethoxazole and Trimethoprim Tablets and August 1, 1993 Do http://www.fda.gov/cder/guidance/index.htm
Oral Suspension Division of Drug Information (HFD-200), Office
of Training and Communications, Center for
Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Theophylline Immediate-Release Dosage Forms February 1, 1995 Do Division of Drug Information (HFD-200), Office
of Training and Communications, Center for
Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Theophylline Intravenous Dosage Forms September 1, 1995 Do http://www.fda.gov/cder/guidance/index.htm
Division of Drug Information (HFD-200), Office
of Training and Communications, Center for
Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Thiamine Hydrochloride Injection February 1, 1988 Do Division of Drug Information (HFD-200), Office
of Training and Communications, Center for
Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tobramycin Sulfate Injection USP May 1, 1993 Do http://www.fda.gov/cder/guidance/index.htm
Division of Drug Information (HFD-200), Office
of Training and Communications, Center for
Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Venlafaxine Hydrochloride Tablets October 1, 1997 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Verapamil Hydrochloride Tablets October 1, 1991 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Vitamin A Capsules February 1, 1992 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Zolpidem Tartrate Tablets September 1, 1997 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Demonstration of Comparability of Human April 1, 1996 Microbiology Do
Biological Products, Including Therapeutic
Biotechnology-Derived Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Labeling OTC Human Drug Products--Submitting December 19, 2000 OTC Draft Do
Requests for Exemptions and Deferrals--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Labeling OTC Human Drug Products: Updating February 22, 2001 Do Do
Labeling in ANDAs--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
OTC Actual Use Studies--Draft July 22, 1994 Do Division of Drug Information (HFD-200), Office
of Training and Communications, Center for
Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
OTC Nicotine Substitutes--Draft March 1, 1994 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53877]]
Enforcement Policy on Marketing OTC Combination OTC http://www.fda.gov/cder/guidance/index.htm
Products (CPG 7132b.16) Division of Drug Information (HFD-200), Office
of Training and Communications, Center for
Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
General Guidelines for OTC Combination Products Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Labeling OCT Human Drug Products Using a Column December 19, 2000 Do Do
Format
--------------------------------------------------------------------------------------------------------------------------------------------------------
Upgrading Category III Antiperspirants to Do Do
Category 1 (43 FR 46728-46731)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Carcinogenicity Study Protocol Submissions-- November 7, 2000 Pharmacology/Toxicology Do
Draft Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Immunotoxicology Evaluation of Investigational May 11, 2001 Do Do
New Drugs--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Photosafety Testing--Draft January 10, 2000 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Statistical Aspects of the Design, Analysis, May 8, 2001 Do Do
and Interpretation of Chronic Rodent
Carcinogenicity Studies of Pharmaceuticals--
Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Content and Format of INDs for Phase 1 Studies October 4, 2000 Pharmacology/Toxicology Do
of Drugs Including Well-Characterized,
Therapeutic, Biotechnology-Derived Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Format and Content of the Nonclinical February 1, 1987 Do Do
Pharmacology/Toxicology Section of an
Application
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nonclinical Pharmacology/Toxicology Development October 16, 1996 Do Do
of Topical Drugs Intended to Prevent the
Transmission of Sexually Transmitted Diseases
(STD) and/or for the Development of Drugs
Intended to Act as Vaginal Contraceptives
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reference Guide for the Nonclinical Toxicity February 1, 1989 Do Do
Studies of Antiviral Drugs Indicated for the
Treatment of N/A Non-Life Threatening Disease:
Evaluation of Drug Toxicity Prior to Phase I
Clinical Studies
--------------------------------------------------------------------------------------------------------------------------------------------------------
Single Dose Acute Toxicity Testing Toxicity August 26, 1996 Do Do
Testing for Pharmaceuticals
--------------------------------------------------------------------------------------------------------------------------------------------------------
Applications Covered by Section 505(b)(2)-- December 8, 1999 Procedural Draft Do
Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Content and Format of New Drug Applications and March 10, 2000 Do Do
Abbreviated New Drug Applications for Certain
Positron Emission Tomography Drug Products--
Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Disclosing Information Provided to Advisory December 22, 1999 Do Do
Committees in Connection With Open Advisory
Committee Meetings Related to the Testing or
Approval of New Drugs and Convened by CDER,
Beginning January 1, 2000--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53878]]
Forms for Registration of Producers of Drugs May 15, 2001 Do Do
and Listing of Drugs in Commercial
Distribution--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Information Program on Clinical Trials for March 29, 2000 Do Do
Serious or Life-Threatening Diseases:
Establishment of a Data Bank--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Information Program on Clinical Trials for July 9, 2001 Do Do
Serious or Life-Threatening Diseases:
Implementation Plan--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Information Request and Discipline Review August 17, 1999 Do Do
Letters Under the Prescription Drug User Fee
Act--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
PET Drug Applications--Content and Format for March 10, 2000 Do Do
NDAs and ANDAs--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Postmarketing Safety Reporting for Human Drug March 12, 2001 Do Do
and Biological Products Including Vaccines--
Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Potassium Iodide as a Thyroid Blocking Agent in January 4, 2001 Do Do
Radiation Emergencies--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reports on the Status of Postmarketing Studies-- April 4, 2001 Do Do
Implementation of Section 130 of the Food and
Drug Administration Modernization Act of 1997--
Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Special Protocol Assessment--Draft February 9, 2000 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submitting Debarment Certification Statements-- October 2, 1998 Do Do
Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
180-Day Generic Drug Exclusivity Under the July 14, 1998 Procedural Do
Hatch-Waxman Amendments to the Federal Food,
Drug, and Cosmetic Act
--------------------------------------------------------------------------------------------------------------------------------------------------------
Advisory Committees: Implementing Section 120 November 2, 1998 Do Do
of the Food and Drug Modernization Act of 1997
--------------------------------------------------------------------------------------------------------------------------------------------------------
Court Decisions, ANDA Approvals, and 130-Day March 30, 2000 Do Do
Exclusivity Under the Hatch-Waxman Amendments
to the Federal Food, Drug, and Cosmetic Act
--------------------------------------------------------------------------------------------------------------------------------------------------------
Disclosure of Materials Provided to Advisory November 30, 1999 Do Do
Committees in Connection With Open Advisory
Committee Meetings Convened by the Center for
Drug Evaluation and Research Beginning on
January 1, 2000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Enforcement Policy During Implementation of November 23, 1998 Do Do
Section 503A of the Federal Food, Drug, and
Cosmetic Act
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fast Track Drug Development Programs: November 18, 1998 Do Do
Designation, Development, and Application
Review
--------------------------------------------------------------------------------------------------------------------------------------------------------
Financial Disclosure by Clinical Investigators March 20, 2001 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Formal Dispute Resolution: Appeals Above the March 7, 2000 Do Do
Division Level
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53879]]
Formal Meetings With Sponsors and Applicants March 7, 2000 Do Do
for PDUFA Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Implementation of Section 120 of the FDA November 20, 1998 Do Do
Modernization Act of 1997--Advisory Committees
--------------------------------------------------------------------------------------------------------------------------------------------------------
Implementation of Section 126 of the FDA July 21, 1998 Do Do
Modernization Act of 1997--Elimination of
Certain Labeling Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
Levothyroxine Sodium Products--Enforcement of July 13, 2001 Do Do
August 14, 2001, Compliance Date and
Submission of New Applications
--------------------------------------------------------------------------------------------------------------------------------------------------------
National Uniformity for Nonprescription Drugs April 9, 1998 Do Do
Ingredient Labeling for OTC Drugs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Qualifying for Pediatric Exclusivity Under October 1, 1999 Do Do
Section 505A of the Federal Food, Drug, and
Cosmetic Act--Revised
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reduction of Civil Money Penalties for Small March 20, 2001 Do Do
Business Entities
--------------------------------------------------------------------------------------------------------------------------------------------------------
Refusal to File July 12, 1993 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Repeal of Section 507 of the Federal Food, June 15, 1998 Do Do
Drug, and Cosmetic Act
--------------------------------------------------------------------------------------------------------------------------------------------------------
Standards for the Prompt Review of Efficacy May 15, 1998 Do Do
Supplements Including Priority Efficacy
Supplements
--------------------------------------------------------------------------------------------------------------------------------------------------------
Women and Minorities Guidance Requirements July 20, 1998 Do Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Information Request and Discipline Review August 17, 1999 User Fee Draft Do
Letters Under the Prescription Drug User Fee
Act
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submitting Separate Marketing Applications and February 22, 2001 Do Do
Definitions of Clinical Data for Purposes of
Assessing User Fees--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Waivers of and Reductions in User Fees July 16, 1993 Do Do
(Attachment G)--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Applicability of User Fees to: (1) Applications July 12, 1993 User Fee Do
Withdrawn Before Filing Decision, or (2)
Applications the Agency Has Refused to File
and That Are Resubmitted or Filed Over Protest
(Attachment F)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Application, Product, and Establishment Fees: December 16, 1994 Do Do
Common Issues and Their Resolution (Attachment
D)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Classifying Resubmissions in Response to Action May 14, 1998 Do Do
Letters
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fees-Exceed-the-Costs Waivers Under the August 25, 1999 Do Do
Prescription Drug User Fee Act
--------------------------------------------------------------------------------------------------------------------------------------------------------
Formal Meetings With Sponsors and Applicants March 7, 2000 Do Do
for PDUFA Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submitting and Reviewing Complete Responses to October 26, 2000 Do Do
Clinical Holds (Revised)
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53880]]
Withdrawals
--------------------------------------------------------------------------------------------------------------------------------------------------------
Intended User or Regulatory
Name of Document Date of Issuance Activity Date of Withdrawal
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dissemination and Reprints of Certain Published Original October 8, 1996 Advertising February 16, 2000
Data (No Replacement)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Funded Dissemination of Reference Texts (No Replacement) October 8, 1996 Advertising February 16, 2000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Buspirone Hydrochloride Tablets In Vivo Bioequivalence (No May 14, 1998 Biopharmaceutics November 30, 2000
Replacement)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cimetidine Tablets In Vivo Bioequivalence and In Vitro Unknown Biopharmaceutics November 30, 2000
Dissolution (No Replacement)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Diclofenac Sodium (Tablets) In Vivo Bioequivalence and In October 6, 1994 Biopharmaceutics November 30, 2000
Vitro Dissolution Testing (No Replacement)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Glipizide In Vivo Bioequivalence and In Vivo Dissolution Unknown Biopharmaceutics November 30, 2000
Testing (No Replacement)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Glyburide In Vivo Bioequivalence and In Vivo Dissolution Unknown Biopharmaceutics November 30, 2000
Testing (No Replacement)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Oral Extended (Controlled) Release Dosage Forms In Vivo Unknown Biopharmaceutics November 30, 2000
Bioequivalence and In Vitro Dissolution Testing (No
Replacement)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Statistical Procedures for Bioequivalence Studies Using a July 1, 1992 Biopharmaceutics November 30, 2000
Standard Two-Treatment Crossover Design (No Replacement)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Drugs to Prevent Dental Caries (No November 1, 1978 Clinical Medical May 18, 2000
Replacement)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Drugs to Prevent, Control, and/or November 1, 1978 Clinical Medical May 18, 2000
Treat Periodontal Disease (No Replacement)
--------------------------------------------------------------------------------------------------------------------------------------------------------
OTC Treatment of Hypercholesterolemia (No Replacement) October 27, 1997 OTC August 3, 2000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Levothyroxine Sodium: Questions and Answers (Replaced by March 8, 2001 Procedural July 13, 2001
Levothyroxine Sodium Products Enforcement of August 14,
2001, Compliance Date and Submission of New Applications
issued on July 13, 2001)
--------------------------------------------------------------------------------------------------------------------------------------------------------
IV. Guidance Documents Issued by the Center for Devices and Radiological Health (CDRH)
--------------------------------------------------------------------------------------------------------------------------------------------------------
How to Obtain a Hard Copy
Intended User or of the Document (Name and
Name of Document Date of Issuance Regulatory Activity Address, Phone, FAX, E- FOD No.
mail or Internet)
--------------------------------------------------------------------------------------------------------------------------------------------------------
The FDA Export Reform and Enhancement Act of 1996/Export February 7, 2000 Office of Compliance (OC) Division of Small 865
Certification Package Including ``Instructions for Manufacturers
Requests for Certificate to Foreign Governments'' Assistance; 1-800-638-
2041 or 301-827-0111 or
(FAX) Facts-on-Demand
(FOD) at 1-800-899-0381
or Internet at http://www.fda.gov/ cdrh/
ggpmain.html
--------------------------------------------------------------------------------------------------------------------------------------------------------
Commercial Distribution/Exhibit Letter April 10, 1992 OC Do 246
--------------------------------------------------------------------------------------------------------------------------------------------------------
Color Additive Status List (Inspection Operations February 1, 1989 OC Do 268
Manual)
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDA Guide for Validation of Biological Indicator January 1, 1986 OC Do 283
Incubation Time
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53881]]
Guide for Establishing and Maintaining a Calibration March 1, 1988 OC Do 286
Constancy Intercomparison System for Microwave Oven
Compliance Survey Instruments (FDA 88-8264)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Preproduction Quality Assurance Planning: September 1, 1989 OC Do 295
Recommendations for Medical Device Manufacturers (FDA
90-4236)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Color Additive Petitions (p. 11-19 of PMA Manual) June 1, 1987 OC Do 296
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Preparation of PMA Manufacturing August 1, 1992 OC Do 448
Information
--------------------------------------------------------------------------------------------------------------------------------------------------------
Civil Money Penalty Policy; Guidance for FDA Staff June 8, 1999 OC Do 1124
--------------------------------------------------------------------------------------------------------------------------------------------------------
General Principles of Software Validation; Draft June 9, 1997 OC Do 938
Guidance
--------------------------------------------------------------------------------------------------------------------------------------------------------
Classification Names for Medical Devices and In Vitro March 1, 1995 OC Do 10
Diagnostic Products (FDA Pub. No. 95-4246)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cover Letter/Guidance Document on the Performance March 9, 1998 OC Do 1197
Standard for Electrode Lead Wires and Patient Cable
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Medical Device Tracking [FDAMA]; Guidance January 24, 2000 OC Do 169
for Industry and FDA Staff
--------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Program Guidance Manual: Inspection of August 12, 1999 OC Do 1702
Medical Devices; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Procedures for Laboratory Compliance Testing of May 1, 1986 OC Do 945
Television Receivers--Part of TV Packet
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 300.600 Commercial Distribution with Regard to September 24, 1987 OC Do 181
Premarket Notification [510(k)] [CPG 7124.19]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter to Medical Device Manufacturer on Pentium February 14, 1995 OC Do 456
Processors
--------------------------------------------------------------------------------------------------------------------------------------------------------
Implementation of the Biomaterials Access Assurance Act April 2, 2001 OC Do 1324
of 1998
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline for the Monitoring of Clinical Investigations January 1, 1988 OC Do 428
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulating In Vitro Diagnostic Device (IVD) Studies; December 17, 1999 OC/Division of Do 1132
Guidance for FDA Staff Bioresearch Monitoring
(DBM)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Preparing Notices of Availability of Investigational March 19, 1999 OC/DBM Do 2229
Medical Devices and for Recruiting Study Subjects
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Electrosurgical Devices and the Application November 15, 1999 OC/Division of Do 1129
of the Performance Standard for Electrode Lead Wires Enforcement (DOE) I
and Patient Cables
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Quality System Regulation Information for August 3, 1999 OC/DOEII Do 1140
Various Premarket Submissions; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Surveillance and Detention Without Physical Examination July 26, 2000 OC/DOEII Do 1141
of Surgeons' and/or Patient Examination Gloves;
Guidance for Industry--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Manufacturers/Assemblers of Diagnostic X-Ray Systems: October 13, 1993 OC/DOEI Do 116
Enforcement Policy for Positive-Beam Limitation (PBL)
Requirements in 21 CFR 1020.31(g)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for the Submission of Initial Reports on January 1, 1982 OC/DOEI Do 257
Diagnostic X-Ray Systems and their Major Components
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53882]]
Exemption From Reporting and Recordkeeping Requirements September 16, 1981 OC/DOEI Do 343
for Certain Sunlamp Product Manufacturers
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter to Medical Device Industry on Endoscopy and May 17, 1993 OC/DOEI Do 545
Laparoscopy Accessories (Galdi)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clarification of Radiation Control Regulations for March 1, 1989 OC/DOEI Do 758
Diagnostic X-Ray Equipment (FDA 89-8221)
--------------------------------------------------------------------------------------------------------------------------------------------------------
CPG 7133.19: Retention of Microwave Oven Test Record/ March 1, 1995 OC/DOEI Do 880
Cover Letter: 08/24, 1981 Retention of Records Required
by 21 CFR [Part] 1002
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline for the Manufacture of In Vitro Diagnostic January 10, 1994 OC/DOEI Do 918
Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
A Guide for the Submission of Abbreviated Radiation March 1, 1996 OC/DOEI Do 977
Safety Reports on Cephalometric X-Ray Devices: Defined
as Dental Units With an Attachment for Mandible Work
That Holds a Cassette and Beam Limiting Device
--------------------------------------------------------------------------------------------------------------------------------------------------------
A Guide for the Submission of an Abbreviated Radiation March 1, 1996 OC/DOEI Do 978
Safety Report on X-Ray Tables, Cradles, Film Changers
or Cassette Holders Intended for Diagnostic Use
--------------------------------------------------------------------------------------------------------------------------------------------------------
A Guide for the Submission of Abbreviated Radiation March 1, 1996 OC/DOEI Do 979
Safety Reports on Image Receptor Support Devices for
Mammographic X-Ray Systems
--------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Program Guidance Manual; Field Compliance March 15, 2000 OC/DOEI Do 1133
Testing of Diagnostic (Medical) X-Ray Equipment;
Guidance for FDA Staff
--------------------------------------------------------------------------------------------------------------------------------------------------------
Information Disclosure by Manufacturers to Assemblers April 2, 2001 OC/DOEI Do 2619
for Diagnostic X-Ray Systems; Final Guidance for
Industry and FDA
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for Submission of Information on Accelerators April 1, 1971 OC/DOEI&III Do 235
Intended to Emit X-Radiation Required Pursuant to 21
CFR 1002.10
--------------------------------------------------------------------------------------------------------------------------------------------------------
Abbreviated Reports on Radiation Safety for Microwave August 1, 1995 OC/DOEI&III Do 236
Products (Other Than Microwave Ovens)--E.G. Microwave
Heating, Microwave Diathermy, RF Sealers, Induction,
Dielectric Heaters, Security Systems
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for Preparing Reports on Radiation Safety of March 1, 1985 OC/DOEI&III Do 239
Microwave Ovens
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reporting Guide for Laser Light Shows and Displays (21 September 1, 1995 OC/DOEI&III Do 251
CFR [Part] 1002) (FDA 88-8140)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for Filing Annual Reports for X-Ray Components and July 1, 1980 OC/DOEI&III Do 253
Systems
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reporting and Compliance Guide for Television Products October 1, 1995 OC/DOEI&III Do 260
Including Product Report, Supplemental Report,
Radiation Safety Abbreviated Report, Annual Report,
Information and Guidance
--------------------------------------------------------------------------------------------------------------------------------------------------------
Revised Guide for Preparing Annual Reports on Radiation September 1, 1995 OC/DOEI&III Do 264
Safety Testing of Laser and Laser Light Show Products
(Replaces FDA 82-8127)
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53883]]
Guide for Preparing Abbreviated Reports of Microwave and September 1, 1996 OC/DOEI&III Do 399
RF Emitting Electronic Products Intended for Medical
Use
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter to Manufacturers and Importers of Microwave October 31, 1988 OC/DOEI&III Do 697
Ovens: Information Requirements for Cookbooks and User
and Service Manuals
--------------------------------------------------------------------------------------------------------------------------------------------------------
Abbreviated Reports on Radiation Safety of Non-Medical August 1, 1995 OC/DOEI&III Do 951
Ultrasonic Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for Preparing Product Reports for Medical September 1, 1996 OC/DOEI&III Do 960
Ultrasound Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter--Manufacturers, Distributors and Importers of February 23, 1994 OC/DOEII Do 52
Condom Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter--Manufacturers, Importers, and Repackagers of February 13, 1989 OC/DOEII Do 53
Condoms for Contraception or Sexually-Transmitted
Disease Prevention (Holt)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter--Condom Manufacturers and Distributors April 5, 1994 OC/DOEII Do 56
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter to Manufacturers/Repackers Using Cotton April 22, 1994 OC/DOEII Do 101
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for Preparing Product Reports for Lasers and September 1, 1995 OC/DOEII Do 277
Products Containing Lasers
--------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Guide for Laser Products (FDA 86-8260) September 1, 1985 OC/DOEII Do 278
--------------------------------------------------------------------------------------------------------------------------------------------------------
Condoms: Inspection and Sampling at Domestic April 8, 1987 OC/DOEII Do 293
Manufacturers and of All Repackers; Sampling From All
Importers (Damaska Memo to Field on 4/8, 1987)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dental Handpiece Sterilization (Dear Doctor Letter) September 28, 1992 OC/DOEII Do 589
--------------------------------------------------------------------------------------------------------------------------------------------------------
Latex Labeling Letter (Johnson) March 18, 1993 OC/DOEII Do 831
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pesticide Regulation Notice 94-4: Interim Measures for June 30, 1994 OC/DOEII Do 851
the Registration of Antimicrobial Products/Liquid
Chemical Germicides With Medical Device Use Claims
Under the Memorandum of Understanding Between EPA and
FDA
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter to Industry, Powered Wheelchair Manufacturers May 10, 1993 OC/DOEII Do 869
From RM Johnson
--------------------------------------------------------------------------------------------------------------------------------------------------------
Hazards of Volume Ventilators and Heated Humidifiers September 15, 1993 OC/DOEII Do 901
--------------------------------------------------------------------------------------------------------------------------------------------------------
Manufacturers and Initial Distributors of Sharps February 3, 1994 OC/DOEII Do 933
Containers and Destroyers Used by Health Care
Professionals
--------------------------------------------------------------------------------------------------------------------------------------------------------
Ethylene Oxide; Ethylene Chlorohydrin; and Ethylene June 23, 1978 OC/DOEII Do 1019
Glycol; Proposed Maximum Residue Limits and Maximum
Levels of Exposure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter to: Manufacturers and Users of Lasers for October 10, 1996 OC/DOEII Do 1093
Refractive Surgery [Excimer]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Shielded Trocars and Needles Used for Abdominal Access August 23, 1996 OC/DOEII Do 1122
During Laparoscopy
--------------------------------------------------------------------------------------------------------------------------------------------------------
Surveillance and Detention Without Physical Examination August 14, 2000 OC/DOEII Do 1139
of Condoms; Guidance for Industry; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
All U.S. Condom Manufacturers, Importers and Repackagers April 7, 1987 OC/DOEII Do 2510
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53884]]
Manufacturers and Initial Distributors of Hemodialyzers May 23, 1996 OC/DOEII Do 2507
--------------------------------------------------------------------------------------------------------------------------------------------------------
Laser Light Show Safety--Who's Responsible? (FDA 86- May 1, 1986 OC/DOEIII Do 13
8262)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Suggested State Regulations for Control of Radiation-- January 1, 1982 OC/DOEIII Do 70
Volume II Nonionizing Radiation--Lasers (FDA Pub. No.
83-8220)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter to All Foreign Manufacturers and Importers of May 28, 1981 OC/DOEIII Do 231
Electronic Products for Which Applicable FDA
Performance Standards Exist
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for Submission of Information on Industrial X-Ray March 1, 1973 OC/DOEIII Do 237
Equipment Required Pursuant to 21 CFR 1002.10
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for Submission of Information on Analytical X-Ray April 30, 1974 OC/DOEIII Do 240
Equipment Required Pursuant to 21 CFR 1002.10
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Submission of Cabinet X-Ray System February 1, 1975 OC/DOEIII Do 241
Reports Pursuant to 21 CFR 1020.40
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for Preparing Annual Reports on Radiation Safety October 1, 1987 OC/DOEIII Do 243
Testing of Electronic Products (General)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Computerized Devices/Processes Guidance--Application of May 1, 1992 OC/DOEIII Do 247
the Medical Device GMP to Computerized Devices and
Manufacturing Processes
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for Preparing Product Reports for Ultrasonic August 1, 1996 OC/DOEIII Do 249
Therapy Products (Physical Therapy Only)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for Submission of Information on Industrial September 1, 1980 OC/DOEIII Do 254
Radiofrequency Dielectric Heater and Sealer Equipment
Pursuant to 21 CFR 1002.10 and 1002.12 (FDA 81-8137)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for Preparing Annual Reports for Ultrasonic September 1, 1996 OC/DOEIII Do 261
Therapy Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for Preparing Annual Reports on Radiation Safety September 1, 1995 OC/DOEIII Do 262
Testing of Sunlamps and Sunlamp Products (Replaces FDA
82-8127)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for Preparing Annual Reports on Radiation Safety September 1, 1995 OC/DOEIII Do 263
Testing of Mercury Vapor Lamps (Replaces FDA 82-8127)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Quality Control Guide for Sunlamp Products (FDA 88-8234) March 1, 1988 OC/DOEIII Do 270
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for the Submission of Initial Reports on Computed September 1, 1984 OC/DOEIII Do 271
Tomography X-Ray Systems
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for Preparing Product Reports on Sunlamps and September 1, 1995 OC/DOEIII Do 279
Sunlamp Products (21 CFR [Part] 1002)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter: Policy on Maximum Timer Interval and Exposure August 21, 1986 OC/DOEIII Do 342
Schedule for Sunlamp Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reporting Guide for Product Reports on High Intensity September 1, 1995 OC/DOEIII Do 348
Mercury Vapor Discharge Lamps (21 CFR [Part] 1002)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Quality Control Practices for Compliance With the May 1, 1980 OC/DOEIII Do 349
Federal Mercury Vapor Lamp Performance Standard
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53885]]
Keeping Up With the Microwave Revolution (FDA Pub. No. March 1, 1990 OC/DOEIII Do 356
91-4160)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Quality Assurance Guidelines for Hemodialysis Devices February 1, 1991 OC/DOEIII Do 507
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter to Manufacturers and Importers of Microwave March 28, 1980 OC/DOEIII Do 646
Ovens--Open Door Operation of Microwave Ovens as a
Result of Oven Miswiring
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reporting of New Model Numbers to Existing Model June 14, 1983 OC/DOEIII Do 675
Families
--------------------------------------------------------------------------------------------------------------------------------------------------------
Import: Radiation-Producing Electronic Products (FDA 89- November 1, 1988 OC/DOEIII Do 756
8008)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Unsafe Patient Lead Wires and Cables September 3, 1993 OC/DOEIII Do 889
--------------------------------------------------------------------------------------------------------------------------------------------------------
Application for a Variance from 21 CFR 1040.11(c) for a July 1, 1998 OC/DOEIII Do 903
Laser Light Show, Display, or Device [Form FDA 3147]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter to Trade Association: Reuse of Single-Use or December 27, 1995 OC/DOEIII Do 961
Disposable Medical Devices
--------------------------------------------------------------------------------------------------------------------------------------------------------
Design Control Guidance for Medical Device Manufacturers March 11, 1997 OC/DOEIII Do 994
--------------------------------------------------------------------------------------------------------------------------------------------------------
Keeping Medical Devices Safe From Electromagnetic July 1, 1995 OC/DOEIII Do 1081
Interference
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medical Devices and EMI: The FDA Perspective January 1, 1995 OC/DOEIII Do 1082
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medical Device Electromagnetic Interference Issues, OC/DOEIII Do 1086
Problem Reports, Standards, and Recommendations
--------------------------------------------------------------------------------------------------------------------------------------------------------
Safety of Electrically Powered Products: Letter to September 18, 1996 OC/DOEIII Do 1087
Medical Device and Electronic Product Manufacturers
From Lillian Gill and BHB Correction Memo
--------------------------------------------------------------------------------------------------------------------------------------------------------
Enforcement Priorities for Single-Use Devices August 14, 2000 OC/DOEIII Do 1168
Reprocessed by Third Parties and Hospitals; Guidance
for Industry and for FDA Staff
--------------------------------------------------------------------------------------------------------------------------------------------------------
Labeling for Electronic Anti-Theft Systems; Guidance for August 15, 2000 OC/DOEIII Do 1170
Industry; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Wireless Medical Telemetry Risks and Recommendations, September 27, 2000 OC/DOEIII Do 1173
Guidance for Industry; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Policy on Warning Label Required on Sunlamp Products June 25, 1985 OC/DOEIII Do 1343
--------------------------------------------------------------------------------------------------------------------------------------------------------
Policy on Lamp Compatibility (Sunlamps) September 2, 1986 OC/DOEIII Do 2343
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry on the Likelihood of Facilities August 5, 1999 OC/Division of Program Do 1269
Inspections When Modifying Devices Subject to Premarket Operations (DPO)
Approval
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on IDE Policies and Procedures [FDAMA]; Final January 20, 1998 Office of Device Do 882
Evaluation (ODE)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Color Additives for Medical Devices November 15, 1995 ODE Do 575
--------------------------------------------------------------------------------------------------------------------------------------------------------
Preamendment Class III Devices March 11, 1992 ODE Do 584
--------------------------------------------------------------------------------------------------------------------------------------------------------
Viable Bacteriophage in CO2 Laser Plume: Aerodynamic Date not available ODE Do 595
Size Distribution
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Submitting Reclassification Petition June 1, 1989 ODE Do 609
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53886]]
Electromagnetic Compatibility for Medical Devices: June 13, 1995 ODE Do 639
Issues and Solutions; Memorandum
--------------------------------------------------------------------------------------------------------------------------------------------------------
SMDA Changes--Premarket Notification; Regulatory April 17, 1992 ODE Do 655
Requirements for Medical Devices [510(k)] Manual Insert
--------------------------------------------------------------------------------------------------------------------------------------------------------
``Real-Time'' Review Program for Premarket Approval April 22, 1997 ODE Do 673
Application (PMA) Supplements
--------------------------------------------------------------------------------------------------------------------------------------------------------
Classified Convenience Kits April 30, 1993 ODE Do 789
--------------------------------------------------------------------------------------------------------------------------------------------------------
30-Day Notices and 135-Day PMA Supplements for February 19, 1998 ODE Do 795
Manufacturing Method or Process Changes, Guidance for
Industry and CDRH [FDAMA]; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Suggested Content for Original IDE Application Cover February 27, 1996 ODE Do 797
Letter--Version 4
--------------------------------------------------------------------------------------------------------------------------------------------------------
Device Specific Guidance Documents (List) May 11, 1993 ODE Do 815
--------------------------------------------------------------------------------------------------------------------------------------------------------
PMA Shell Development and Modular Review; Guidances for November 6, 1998 ODE Do 835
the Medical Device Industry; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Determination of Intended Use for 510(k) Devices-- January 30, 1998 ODE Do 857
Guidance for Industry and CDRH Staff [FDAMA]; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Premarket Notification [510(k)] Status Request Form, March 14, 1997 ODE Do 858
Revised
--------------------------------------------------------------------------------------------------------------------------------------------------------
CDRH's 510(k)/IDE/PMA Refuse to Accept/Accept/File June 30, 1993 ODE Do 859
Policies
--------------------------------------------------------------------------------------------------------------------------------------------------------
Indications for Use Statement February 6, 1996 ODE Do 879
--------------------------------------------------------------------------------------------------------------------------------------------------------
The New 510(k) Paradigm--Alternate Approaches to March 20, 1998 ODE Do 905
Demonstrating Substantial Equivalence in Premarket
Notifications; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Preamendments Class III Strategy; SXAlpert April 19, 1994 ODE Do 611
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter to Industry, Powered Wheelchair/Scooter or May 26, 1994 ODE Do 883
Accessory/Component Manufacturer From Susan Alpert,
Ph.D., M.D.
--------------------------------------------------------------------------------------------------------------------------------------------------------
ODE Executive Secretary Guidance Manual August 7, 1987 ODE Do 1338
--------------------------------------------------------------------------------------------------------------------------------------------------------
Modifications to Devices Subject to Premarket Approval-- August 6, 1998 ODE Do 102
The PMA Supplement Decision Making Process; Guidance
for Industry; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
CDRH Submissions Coversheet [PMA/PDP/510k/IDE] May 8, 1998 ODE Do 147
--------------------------------------------------------------------------------------------------------------------------------------------------------
Procedures for Class II Device Exemptions from Premarket February 19, 1998 ODE Do 159
Notification, Guidance for Industry and CDRH Staff
[FDAMA]; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Limulus Amebocyte Lysate; Reduction of Samples for October 23, 1987 ODE Do 178
Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
Labeling Reusable Medical Devices for Reprocessing in April 1, 1996 ODE Do 198
Health Care Facilities: FDA Reviewer Guidance
--------------------------------------------------------------------------------------------------------------------------------------------------------
New Section 513(f)(2)--Evaluation of Automatic Class III February 19, 1998 ODE Do 199
Designation; Guidance for Industry and CDRH Staff
[FDAMA]; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53887]]
Methods for Conducting Recall Effectiveness Checks June 16, 1978 ODE Do 225
--------------------------------------------------------------------------------------------------------------------------------------------------------
Suggestions for Submitting a Premarket Approval (PMA) April 1, 1993 ODE Do 228
Application
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Off-the-Shelf Software Use in Medical September 9, 1999 ODE Do 1252
Devices; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Application of the Device Good Manufacturing Practice December 1, 1983 ODE Do 267
(GMP) Regulation to the Manufacture of Sterile Devices
--------------------------------------------------------------------------------------------------------------------------------------------------------
Points to Consider in the Characterization of Cell Lines June 1, 1984 ODE Do 269
Used to Produce Biological Products (From John C.
Petricciani, M.D.)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Early Collaboration Meetings Under the FDA Modernization February 19, 1998 ODE Do 310
Act (FDAMA), Guidance for Industry and CDRH Staff
[FDAMA]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Format for IDE Progress Reports June 1, 1996 ODE Do 311
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on PMA Interactive Procedures for Day-100 February 19, 1998 ODE Do 322
Meetings and Subsequent Deficiencies--For Use by CDRH
and Industry [FDAMA]; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Industry Representatives on Scientific Panels March 27, 1987 ODE Do 329
--------------------------------------------------------------------------------------------------------------------------------------------------------
PMA Review Schedule [P87-1] March 31, 1988 ODE Do 333
--------------------------------------------------------------------------------------------------------------------------------------------------------
Necessary Information for Diagnostic Ultrasound 510(k) November 24, 1987 ODE Do 335
(Draft)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket Submissions for May 29, 1998 ODE Do 337
Software Contained in Medical Devices; Guidance for FDA
and Reviewers and Industry; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Master Files Part III; Guidance on Scientific and June 1, 1987 ODE Do 338
Technical Information
--------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) Quality Review Program (Blue Book Memo) (I96-1) March 29, 1996 ODE Do 344
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDA Policy for the Regulation of Computer Products November 13, 1989 ODE Do 351
(Draft)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Threshold Assessment of the Impact of Requirements for January 1, 1990 ODE Do 352
Submission of PMAs for 31 Medical Devices Marketed
Prior to May 28, 1976
--------------------------------------------------------------------------------------------------------------------------------------------------------
4-of-A-Kind PMAs October 1, 1991 ODE Do 371
--------------------------------------------------------------------------------------------------------------------------------------------------------
Supplements to Approved Applications for Class III May 20, 1998 ODE Do 380
Medical Devices: Use Published Literature, Use of
Previously Submitted Materials, and Priority Review
[FDAMA]; Guidance for Industry; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Substantial Equivalence (SE) Decision Making January 1, 1990 ODE Do 390
Documentation ATTACHED: ``SE'' Decision Making Process
(Detailed), i.e., the Decision Making Tree
--------------------------------------------------------------------------------------------------------------------------------------------------------
Shelf Life of Medical Devices March 1, 1991 ODE Do 415
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline on General Principles of Process Validation May 1, 1987 ODE Do 425
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline on Sterile Drug Products Produced by Aseptic June 1, 1987 ODE Do 426
Processing
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53888]]
Guideline on Validation of the Limulus Amebocyte Lysate December 1, 1987 ODE Do 427
(LAL) Test as an End-Product Endotoxin Test
--------------------------------------------------------------------------------------------------------------------------------------------------------
General/Specific Intended Use [FDAMA]; Draft Guidance November 4, 1998 ODE Do 499
for Industry
--------------------------------------------------------------------------------------------------------------------------------------------------------
Distribution and Public Availability of Premarket October 10, 1997 ODE Do 563
Approval Application Summary of Safety and
Effectiveness Data Packages [Blue Book Memo #P98-1];
Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Proposal for Establishing Mechanisms for Setting Review June 30, 1993 ODE Do 931
Priorities Using Risk Assessment and Allocating Review
Resources and T93-28 dated 6/25, 1993, Device ``Fast
Track'' Plan Announcement (Include with 926-930)
--------------------------------------------------------------------------------------------------------------------------------------------------------
New Model Medical Device Development Process; Guidance July 21, 1998 ODE Do 1101
for Industry; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on the Use of Standards in Substantial March 12, 2000 ODE Do 1131
Equivalence Determinations; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry and for FDA Reviewers; August 9, 2000 ODE Do 1135
Interpretive Guidance on Section 216 of the Food and
Drug Administration Modernization Act of 1997
--------------------------------------------------------------------------------------------------------------------------------------------------------
Evidence Models for the Least Burdensome Means to September 1, 1999 ODE Do 1154
Market; Guidance for Industry and FDA Reviewers; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Questions and Answers for the FDA Reviewer Guidance: September 3, 1996 ODE Do 1198
Labeling Reusable Medical Devices for Reprocessing in
Health Care Facilities
--------------------------------------------------------------------------------------------------------------------------------------------------------
Deciding When to Submit a 510(k) for a Change to an November 30, 2000 ODE Do 1073
Existing Wireless Telemetry Medical Device; Final
Guidance for FDA Reviewers and Industry
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Amended Procedures for Advisory Panel July 22, 2000 ODE Do 413
Meetings
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medical Devices Containing Materials Derived From Animal November 16, 1998 ODE Do 2206
Sources (Except for In Vitro Diagnostic Devices),
Guidance for FDA Reviewers and Industry; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Frequently Asked Questions on the New 510(k) Paradigm; October 22, 1998 ODE Do 2230
Guidance for Industry; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
The Least Burdensome Provisions of the FDA Modernization May 3, 2001 ODE Do 1332
Act of 1997: Concept and Principles; Draft Guidance for
FDA and Industry
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket Notifications for September 12, 1994 ODE Division of Do 97
Conventional and Antimicrobial Foley Catheters Reproductive, Abdominal,
and Radiological Devices
(DRARD)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Checklist for Mechanical Lithotripters and Stone November 1, 1994 ODE/DRARD Do 98
Dislodgers Used in Gastroenterology and Urology
--------------------------------------------------------------------------------------------------------------------------------------------------------
Convenience Kits Interim Regulatory Guidance (Include May 20, 1997 ODE/510K Do 562
874)
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53889]]
Announcement: Implementation of the FDA/HCFA Interagency September 15, 1995 ODE/BlueBook Do 106
Agreement Regarding Reimbursement Categorization of
Investigational Devices, Att. A Interagency Agreement,
Att. B Criteria for Categorization of Investigational
Devices #D95-2 (Blue Book Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Consolidated Review of Submissions for Diagnostic October 19, 1990 ODE/BlueBook Do 30
Ultrasound Equipment, Accessories and Related
Measurement Devices #G90-2 (Blue Book Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Consolidated Review of Submissions for Lasers and October 19, 1990 ODE/BlueBook Do 31
Accessories #G90-1 (Blue Book Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review of Final Draft Medical Device Labeling #P91-4 August 29, 1991 ODE/BlueBook Do 34
(Blue Book Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review of 510(k)s for Computer Controlled Medical August 29, 1991 ODE/BlueBook Do 35
Devices #K91-1 (Blue Book Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Use of International Standard ISO-10993, ``Biological May 1, 1995 ODE/BlueBook Do 164
Evaluation of Medical Devices Part 1: Evaluation and
Testing'' (Replaces #G87-1 #8294) (Blue Book Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
ODE Regulatory Information for the Office of Compliance-- May 15, 1987 ODE/BlueBook Do 276
Information Sharing Procedures #G87-2 (Blue Book Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Panel Review of ``Me-Too'' Devices #P86-6 (Blue Book July 1, 1986 ODE/BlueBook Do 280
Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on the Center for Devices and Radiological June 30, 1986 ODE/BlueBook Do 289
Health's Premarket Notification Review Program #K86-3
(Blue Book Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
PMA Filing Decisions #P90-2 (Blue Book Memo) May 18, 1990 ODE/BlueBook Do 297
--------------------------------------------------------------------------------------------------------------------------------------------------------
PMAs--Early Review and Preparation of Summaries of January 27, 1986 ODE/BlueBook Do 302
Safety and Effectiveness #P86-1 (Blue Book Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Criteria for Panel Review of PMA Supplements #P86-3 January 30, 1986 ODE/BlueBook Do 304
(Blue Book Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review and Approval of PMAs of Licensees #P86-4 (Blue October 22, 1990 ODE/BlueBook Do 305
Book Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Panel Report and Recommendations on PMA Approvals #P86-5 April 18, 1986 ODE/BlueBook Do 306
(Blue Book Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) Sign-Off Procedures #K94-2 (Blue Book Memo) June 3, 1994 ODE/BlueBook Do 308
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review of Laser Submissions #G88-1 (Blue Book Memo) April 15, 1988 ODE/BlueBook Do 330
--------------------------------------------------------------------------------------------------------------------------------------------------------
Delegation of IDE Actions #D88-1 (Blue Book Memo) April 26, 1988 ODE/BlueBook Do 331
--------------------------------------------------------------------------------------------------------------------------------------------------------
Premarket Notification--Consistency of Reviews #K89-1 February 28, 1989 ODE/BlueBook Do 339
(Blue Book Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Telephone Communications Between ODE Staff and January 29, 1993 ODE/BlueBook Do 360
Manufacturers #I93-1 (Blue Book Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) Sterility Review Guidance--and Revision of 11/18/ February 12, 1990 ODE/BlueBook Do 361
1994 #K90-1 (Blue Book Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review of IDEs for Feasibility Studies #D89-1 (Blue Book May 17, 1989 ODE/BlueBook Do 362
Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53890]]
Toxicology Risk Assessment Committee #G89-1 (Blue Book August 9, 1989 ODE/BlueBook Do 363
Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Assignment of Review Documents #I90-2 (Blue Book Memo) August 24, 1990 ODE/BlueBook Do 366
--------------------------------------------------------------------------------------------------------------------------------------------------------
Meetings With the Regulated Industry #I89-3 (Blue Book November 20, 1989 ODE/BlueBook Do 367
Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Policy Development and Review Procedures #I90-1 (Blue February 15, 1990 ODE/BlueBook Do 368
Book Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
PMA Supplements: ODE Letter to Manufacturers; Identifies April 24, 1990 ODE/BlueBook Do 387
Situations Which May Require the Submission of a PMA
Supplement (When PMA Supplements Are Required) #P90-1
(Blue Book Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) Refuse to Accept Procedures #K94-1 (Blue Book May 20, 1994 ODE/BlueBook Do 401
Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
PMA Refuse to File Procedures #P94-1 (Blue Book Memo) May 20, 1994 ODE/BlueBook Do 402
--------------------------------------------------------------------------------------------------------------------------------------------------------
Premarket Approval Application (PMA) Closure #P94-2 July 8, 1994 ODE/BlueBook Do 403
(Blue Book Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
PMA/510(k) Triage Review Procedures #G94-1 (Blue Book May 20, 1994 ODE/BlueBook Do 404
Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Goals and Initiatives for the IDE Program #D95-1 (Blue July 12, 1995 ODE/BlueBook Do 405
Book Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cover Letter: 510(k) Requirements During Firm-Initiated November 21, 1995 ODE/BlueBook Do 406
Recalls; Attachment A: Guidance on Recall and Premarket
Notification Review Procedures During Firm-Initiated
Recalls of Legally Marketed Devices (Blue Book Memo
#K95-1)
--------------------------------------------------------------------------------------------------------------------------------------------------------
IDE Refuse to Accept Procedures #D94-1 (Blue Book Memo) May 20, 1994 ODE/BlueBook Do 410
--------------------------------------------------------------------------------------------------------------------------------------------------------
Device Labeling Guidance #G91-1 (Blue Book Memo) March 8, 1991 ODE/BlueBook Do 414
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Utility and Premarket Approval #P91-1 (Blue May 3, 1991 ODE/BlueBook Do 443
Book Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Panel Review of Premarket Approval Applications #P91-2 May 3, 1991 ODE/BlueBook Do 444
(Blue Book Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
PMA Compliance Program #P91-3 (Blue Book Memo) May 3, 1991 ODE/BlueBook Do 445
--------------------------------------------------------------------------------------------------------------------------------------------------------
Document Review Processing #I91-1 (Blue Book Memo) February 12, 1992 ODE/BlueBook Do 446
--------------------------------------------------------------------------------------------------------------------------------------------------------
Integrity of Data and Information Submitted to ODE #I91- May 29, 1991 ODE/BlueBook Do 447
2 (Blue Book Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nondisclosure of Financially Sensitive Information #I92- March 5, 1992 ODE/BlueBook Do 587
1 (Blue Book Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Memorandum of Understanding Regarding Patient Labeling August 9, 1996 ODE/BlueBook Do 806
Review (Blue Book Memo #G96-3))
--------------------------------------------------------------------------------------------------------------------------------------------------------
Continued Access to Investigational Devices During PMA July 15, 1996 ODE/BlueBook Do 872
Preparation and Review (Blue Book Memo) (D96-1)
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53891]]
510(k) Additional Information Procedures #K93-1 (Blue July 23, 1993 ODE/BlueBook Do 886
Book Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Overdue IDE Annual Progress Report Procedures #D93-1 July 23, 1993 ODE/BlueBook Do 887
(Blue Book Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Documentation and Resolution of Differences of Opinion December 23, 1993 ODE/BlueBook Do 920
on Product Evaluations #G93-1 (Blue Book Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Deciding When to Submit a 510(k) for a Change to an January 10, 1997 ODE/BlueBook Do 1935
Exisiting Device; (Blue Book Memo #K97-1)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Interagency Agreement Between FDA and HCFA; #D95-2, September 15, 1995 ODE/BlueBook Do 2106
Attachment A
--------------------------------------------------------------------------------------------------------------------------------------------------------
Executive Secretaries Guidance Manual #G87-3 August 7, 1987 ODE/BlueBook Do 2326
--------------------------------------------------------------------------------------------------------------------------------------------------------
Criteria for Categorization of Investigational Devices September 15, 1995 ODE/BlueBook Do 3106
(HCFA); #D95-2, Attachment B
--------------------------------------------------------------------------------------------------------------------------------------------------------
Center for Devices and Radiological Health's Premarket June 30, 1993 ODE/BlueBook Do 3859
Notification [510(k)] Refuse to Accept Policy--(Updated
Checklist March 14, 1995)
--------------------------------------------------------------------------------------------------------------------------------------------------------
HCFA Reimbursement Categorization Determinations for FDA- October 31, 1995 ODE/BlueBook Do 4106
Approved IDEs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Center for Devices and Radiological Health's June 30, 1993 ODE/BlueBook Do 4859
Investigational Device Exemption (IDE) Refuse to Accept
Policy
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Prescription Use Drugs of Abuse Assays November 14, 2000 ODE Division of Clinical Do 152
Premarket Notifications; Guidance for Industry and/or Laboratory Devices
for FDA Reviewers/Staff and/or Compliance; Draft (DCLD)
Guidance--Not for Implementation
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of In Vitro Diagnostic August 31, 1995 ODE/DCLD Do 1191
Devices for Drugs of Abuse Assays Using Various
Methodologies
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Labeling for Over-the-Counter Sample December 21, 1999 ODE/DCLD Do 1359
Collection Systems for Drugs of Abuse Testing; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for In Vitro Diagnostic Devices for the February 1, 1994 ODE/DCLD Do 51
Assessment of Thyroid Autoantibodies Using Indirect
Immunofluorescence Assay (IFA), Indirect
Hemagglutination Assay (IHA), Radioimmunoasay (RIA),
and Enzyme Linked Immunosorbent Assay (ELISA)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for Blood Culture Systems August 12, 1991 ODE/DCLD Do 82
--------------------------------------------------------------------------------------------------------------------------------------------------------
Points to Consider for Collection of Data in Support of September 26, 1994 ODE/DCLD Do 95
In Vitro Device Submissions for 510(k) Clearance
--------------------------------------------------------------------------------------------------------------------------------------------------------
Points to Consider for Portable Blood Glucose Monitoring February 20, 1996 ODE/DCLD Do 122
Devices Intended for Bedside Use in the Neonate Nursery
--------------------------------------------------------------------------------------------------------------------------------------------------------
Criteria for Assessment of In Vitro Diagnostic Devices August 31, 1995 ODE/DCLD Do 1191
for Drugs of Abuse Assays Using Various Methodologies;
Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of Rheumatoid Factor (RF) February 21, 1997 ODE/DCLD Do 165
In Vitro Diagnostic Devices Using Enzyme-Linked
Immunoassay (EIA), Enzyme Linked Immunosorbent Assay
(ELISA), Particle Agglutination Tests, and Laser and
Rate Nephelometry
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53892]]
Assessing the Safety/Effectiveness of Home-Use In Vitro October 1, 1988 ODE/DCLD Do 272
Diagnostic Devices (IVDs): Points to Consider Regarding
Labeling and Premarket Submissions; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Submission of Immunohistochemistry June 3, 1998 ODE/DCLD Do 364
Applications to the FDA; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of Cytogenetic Analysis July 15, 1991 ODE/DCLD Do 417
Using Automated and Semi-Automated Chromosome Analyzers
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of Alpha-Fetoprotein July 15, 1994 ODE/DCLD Do 459
(AFP) In Vitro Diagnostic Devices for Fetal Open Neural
Tube Defects Using Immunological Test Methodologies
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for 510(k) Submission of Lymphocyte September 26, 1991 ODE/ Do 475
Immunophenotyping IVDs using Monoclonal Antibodies;
Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Points to Consider for Hematology Quality Control September 30, 1997 ODE/DCLD Do 512
Materials
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for In Vitro Diagnostic Devices for August 1, 1992 ODE/DCLD Do 527
Detection of IGM Antibodies to Viral Agents
--------------------------------------------------------------------------------------------------------------------------------------------------------
Points to Consider for Review of Calibration and Quality February 1, 1996 ODE/DCLD Do 553
Control Labeling for In Vitro Diagnostic Devices/Cover
Letter Dated March 14, 1996
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for Devices Intended for the Detection December 30, 1991 ODE/DCLD Do 554
of Hepatitis B ``e'' Antigen and Antibody to HBe
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Criteria for Cyclosporine PMAs January 24, 1992 ODE/DCLD Do 564
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of Laboratory Tests for September 17, 1992 ODE/DCLD Do 588
the Detection of Antibodies to Helicobacter Pylori
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of Human Chorionic September 27, 1995 ODE/DCLD Do 592
Gonadotropin (hCG) In Vitro Diagnostic Devices (IVDs)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Premarketing Approval Review Criteria for Premarket September 10, 1992 ODE/DCLD Do 603
Approval of Estrogen (ER) or Progesterone (PGR)
Receptors In Vitro Diagnostic Devices Using Steroid
Hormone Binding (SBA) With Dextran-Coated Charcoal
(DCC) Separation, Histochemical Receptor Bi; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of Portable Blood Glucose February 14, 1996 ODE/DCLD Do 604
In Vitro Diagnostic Devices Using Glucose Oxidase,
Dehydrogenase, or Hexokinase Methodology
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for 510(k)s on Cholesterol Tests for Clinical July 14, 1995 ODE/DCLD Do 605
Laboratory, Physicians' Office Laboratory, and Home Use
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for Devices Assisting in the Diagnosis May 31, 1990 ODE/DCLD Do 629
of C. Difficile Associated Diseases
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for 510(k) Submission of September 30, 1991 ODE/DCLD Do 658
Glycohemoglobin (Glycated or Glycosylated) Hemoglobin
for IVDs; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria For Premarket Approval of In Vitro May 15, 1992 ODE/DCLD Do 770
Diagnostic Devices for Detection of Antibodies to
Parvovirus B19
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53893]]
Guidance Document for 510(k) Submission of Fecal Occult July 29, 1992 ODE/DCLD Do 772
Blood Tests; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of In Vitro Diagnostic January 1, 1992 ODE/DCLD Do 778
Devices for Direct Detection of Chlamydiae in Clinical
Specimens
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for 510(k) Submission of September 1, 1992 ODE/DCLD Do 785
Immunoglobulins A, G, M, D and E Immunoglobulin System
In Vitro Devices; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for the Assessment of Allergen-Specific March 2, 1993 ODE/DCLD Do 800
Immunoglobulin E (IGE) In Vitro Diagnostic Devices
Using Immunological Test Methodologies
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for the Assessment of Anti-Nuclear September 1, 1992 ODE/DCLD Do 848
Antibodies (ANA) In Vitro Diagnostic Devices Using
Indirect Immunofluorescence Assay (IFA),
Immunodiffusion (IMD) and Enzyme Linked Immunosorbant
Assay (ELISA).
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for Nucleic Acid Amplification Based In June 14, 1993 ODE/DCLD Do 861
Vitro Diagnostic Devices for Direct Detection of
Infectious Microorganisms; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of In Vitro Diagnostic July 6, 1993 ODE/DCLD Do 862
Devices for Direct Detection of Mycobacterium Spp.
[Tuberculosis (TB)]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Data for Commercialization of Original Equipment June 10, 1996 ODE/DCLD Do 950
Manufacturer, Secondary and Generic Reagents for
Automated Analyzers
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for the Submission of Tumor Associated September 19, 1996 ODE/DCLD Do 957
Antigen Premarket Notification [510(k)] to FDA
--------------------------------------------------------------------------------------------------------------------------------------------------------
Points to Consider for Cervical Cytology Devices July 25, 1994 ODE/DCLD Do 968
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for In Vitro Diagnostic Devices That February 15, 1996 ODE/DCLD Do 980
Utilize Cytogenetic In Situ Hybridization Technology
for the Detection of Human Genetic Mutations (Germ Line
and Somatic)
--------------------------------------------------------------------------------------------------------------------------------------------------------
In Vitro Diagnostic Bicarbonate/Carbon Dioxide Test July 6, 1998 ODE/DCLD Do 1102
System; Guidance for Industry; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
In Vitro Diagnostic Chloride Test System; Guidance for July 6, 1998 ODE/DCLD Do 1103
Industry; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
In Vitro Diagnostic Creatinine Test System; Guidance for July 2, 1998 ODE/DCLD Do 1104
Industry; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
In Vitro Diagnostic Glucose Test System; Guidance for July 6, 1998 ODE/DCLD Do 1105
Industry; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
In Vitro Diagnostic Potassium Test System; Guidance for July 6, 1998 ODE/DCLD Do 1107
Industry; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
In Vitro Diagnostic Sodium Test System; Guidance for July 6, 1998 ODE/DCLD Do 1109
Industry; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
In Vitro Diagnostic Urea Nitrogen Test System; Guidance July 6, 1998 ODE/DCLD Do 1110
for Industry; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Administrative Procedures for CLIA August 14, 2000 ODE/DCLD Do 1143
Categorization; Guidance for Industry and/or for FDA
Reviewers/Staff and/or Compliance; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53894]]
Guidance for Clinical Laboratory Improvement Amendments March 1, 2001 ODE/DCLD Do 1147
of 1988 (CLIA) Criteria for Waiver; Draft Guidance for
Industry and FDA Applications
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Over-the-Counter (OTC) Ovulation Predictor July 22, 2000 ODE/DCLD Do 1171
510(k)s
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Over-the-Counter (OTC) Human Chorionic July 22, 2000 ODE/DCLD Do 1172
Gonadotropin (hCG) 510(k)s
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Review Criteria for Assessment of March 8, 2000 ODE/DCLD Do 631
Antimicrobial Susceptibility Devices; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
In Vitro Diagnostic C-Reactive Protein Immunological July 20, 1998 ODE/DCLD Do 1246
Test System; Guidance for Industry; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Abbreviated 510(k) Submissions for In Vitro Diagnostic February 22, 1999 ODE/DCLD Do 1247
Calibrators; Guidance for Industry: Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Labeling for Laboratory Tests; Guidance for June 24, 1999 ODE/DCLD Do 1352
Industry; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Premarket Approval Applications for Assays Pertaining to October 8, 1999 ODE/DCLD Do 1353
Hepatitis C Viruses (HCV) That Are Indicated for
Diagnosis or Monitoring of HCV Infection or Associated
Disease; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Class II Special Control Guidance Document for Anti- August 23, 2000 ODE/DCLD Do 1183
Saccharomyces Cerevisiae (S. Cerevisiae) Antibody
(ASCA) Premarket Notifications; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Premarket Notifications for Automated November 1, 2000 ODE/DCLD Do 1184
Differential Cell Counters for Immature or Abnormal
Blood Cells; Final; Guidance for Industry and FDA
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of Antimicrobial October 30, 1996 ODE/DCLD Do 1631
Susceptibility Test Discs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Over the Counter (OTC) Screening Tests for Drugs of November 14, 2000 ODE/DCLD Do 2209
Abuse: Guidance for Premarket Notifications; Guidance
for Industry; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Points to Consider Guidance Document on Assayed and February 3, 1999 ODE/DCLD Do 2231
Unassayed Quality Control Material; Guidance for
Industry
--------------------------------------------------------------------------------------------------------------------------------------------------------
Document for Special Controls for Erythropoietin Assay April 28, 1999 ODE/DCLD Do 2241
Premarket Notifications [510(k)s]; Guidance for
Industry; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
In Vitro Diagnostic Fibrin Monomer Paracoagulation Test; April 27, 1999 ODE/DCLD Do 2242
Guidance for Industry and FDA Reviewers/Staff; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Class II Special Control Guidance Document for B-Type November 30, 2000 ODE/DCLD Do 1072
Natriuretic Peptide Premarket Notifications; Final
Guidance for Industry and FDA Reviewers
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Electrical Safety, Electromagnetic June 28, 2000 ODE Division of Do 1161
Compatibility and Mechanical Testing for Indwelling Cardiovascular and
Blood Gas Analyzer Premarket Notification Submissions Respiratory Devices
(DCRD)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Submission of Research and Marketing November 1, 2000 ODE/DCRD Do 372
Applications for Permanent Pacemaker Leads and for
Pacemaker Lead Adaptor 510(k) Submissions; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53895]]
Investigational Device Exemption (IDE) Study Enrollment November 8, 2000 ODE/DCRD Do 1199
for Cardiac Ablation of Typical Atrial Flutter; Final
Guidance for Industry and FDA Reviewers
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for Vascular Prostheses 510(k) November 1, 2000 ODE/DCRD Do 1357
Submissions; Guidance for Industry and FDA Staff; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Annuloplasty Rings 510(k) Submissions; January 31, 2001 ODE/DCRD Do 1358
Final Guidance for Industry and FDA Staff
--------------------------------------------------------------------------------------------------------------------------------------------------------
1-Consolidated Annual Report for a Device Product Line July 6, 2000 ODE/DCRD Do 1167
(1-CARD); Pilot for Preparation of Annual Reports for
Pacemaker Premarket Approval Applications
--------------------------------------------------------------------------------------------------------------------------------------------------------
Excerpts Related to EMI From November 1993 November 1, 1993 ODE/DCRD Do 638
Anesthesiology and Respiratory Devices Branch
(Including Electromagnetic Compatibility Standard for
Medical Devices; 10/1/79)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Infant/Child Apnea Monitor 510(k) September 22, 2000 ODE/DCRD Do 1178
Submissions
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry and for FDA Reviewers: Recommended May 7, 1999 ODE/DCRD Do 2244
Clinical Study Design for Ventricular Tachycardia
Ablation
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Electro-Optical Sensors for the August 25, 1999 ODE/DCRD Do 266
In Vivo Detection of Cervical Cancer and its
Precursors: Submission Guidance for an IDE/PMA; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Cardiovascular Intravascular Filter 510(k) November 26, 1999 ODE/DCRD Do 24
Submission; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Submission of 510(k) Premarket February 11, 1997 ODE/DCRD Do 25
Notifications for Electrocardiograph (ECG) Electrode--
Version 1.0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Submission of 510(k) Premarket February 11, 1997 ODE/DCRD Do 26
Notifications for Electrocardiograph (ECG) Lead
Switching Adapter--Version 1.0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document Device: Electrocardiograph (ECG) February 11, 1997 ODE/DCRD Do 27
Surface Electrode Tester--Version 1.0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance Outline--Points to Consider for Clinical November 30, 1993 ODE/DCRD Do 100
Studies for Vasovasostomy Devices
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medical Device Labeling--Suggested Format and Content; April 25, 1997 ODE/DCRD Do 119
Draft Document
--------------------------------------------------------------------------------------------------------------------------------------------------------
Non-Invasive Blood Pressure (NIBP) Monitor Guidance March 10, 1997 ODE/DCRD Do 123
--------------------------------------------------------------------------------------------------------------------------------------------------------
Policy for Expiration Dating (DCRD RB92-G) October 30, 1992 ODE/DCRD Do 137
--------------------------------------------------------------------------------------------------------------------------------------------------------
Human Heart Valve Allografts; Draft June 21, 1991 ODE/DCRD Do 224
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Extracorporeal Blood Circuit Defoamer February 16, 2000 ODE/DCRD Do 1632
510(k) Submissions; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Cardiopulmonary Bypass Arterial Line Blood February 21, 2000 ODE/DCRD Do 1622
Filter 510(k) Submissions; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Balloon Valvuloplasty Guidance for the Submission of an January 1, 1989 ODE/DCRD Do 370
IDE Application and a PMA Application
--------------------------------------------------------------------------------------------------------------------------------------------------------
Replacement Heart Valve Guidance; Draft October 14, 1994 ODE/DCRD Do 375
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53896]]
Implantable Pacemaker Testing Guidance January 12, 1990 ODE/DCRD Do 383
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter/Guidance: Vascular Graft Manufacturer, Developer, May 11, 1990 ODE/DCRD Do 391
or Representative
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reviewer Guidance for Ventilators; Draft July 1, 1995 ODE/DCRD Do 500
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft 510(k) Checklist for Urological Irrigation System August 1, 1995 ODE/DCRD Do 515
and Tubing Set
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance to Firms on Biliary Lithotripsy Studies August 2, 1990 ODE/DCRD Do 522
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Clinical Investigations of Devices November 11, 1994 ODE/DCRD Do 533
Used for the Treatment of Benign Prostatic Hyperplasia
(BPH)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter: Notice to Manufacturers of Bone Mineral September 25, 1997 ODE/DCRD Do 552
Densitometers
--------------------------------------------------------------------------------------------------------------------------------------------------------
Information for Manufacturers Seeking Marketing September 30, 1997 ODE/DCRD Do 560
Clearance of Diagnostic Ultrasound Systems and
Transducers: Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for the Content of Premarket January 24, 1992 ODE/DCRD Do 567
Notifications for Urological Balloon Dilatation
Catheters
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline for the Arrangement and Content of a Premarket May 1, 1990 ODE/DCRD Do 577
Approval (PMA) Application for a Cochlear Implant in
Adults at Least 18 Years of Age
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Preparation of the Annual Report to the April 1, 1990 ODE/DCRD Do 582
PMA Approved Heart Valve Prostheses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Version: Electrode Recording Catheter Preliminary March 1, 1995 ODE/DCRD Do 602
Guidance (Data to Be Sumitted to the FDA in Support of
Premarket Notifications [510(k)s])
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cardiac Ablation Preliminary Guidance (Data to Be March 1, 1995 ODE/DCRD Do 619
Submitted to the FDA in Support Investigation Device
Exemption Application; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Premarket Testing Guidelines for Falloposcopes November 20, 1992 ODE/DCRD Do 621
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidelines for Evaluation of Non-Drug IUDs September 28, 1976 ODE/DCRD Do 641
--------------------------------------------------------------------------------------------------------------------------------------------------------
Simplified 510(k) procedures for certain radiology December 21, 1993 ODE/DCRD Do 708
devices: 12/21, 1993, letter from L Yin, ODE/ODE/DRARD,
to NEMA
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft 510(k) Checklist for Endoscopic Electrosurgical August 16, 1995 ODE/DCRD Do 768
Unit (ESU) and Accessories Used in Gastroenterology and
Urology
--------------------------------------------------------------------------------------------------------------------------------------------------------
Heated Humidifier Review Guidance August 30, 1991 ODE/DCRD Do 780
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reviewer Guidance for Nebulizers, Metered Dose Inhalers, October 1, 1993 ODE/DCRD Do 784
Spacers and Actuators
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reviewer Guidance for Automatic X-Ray Film Processor February 1, 1990 ODE/DCRD Do 788
510(k)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Technical Content of a Premarket April 1, 1990 ODE/DCRD Do 791
Approval (PMA) Application for an Endolymphatic Shunt
Tube With Valve
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Magnetic Resonance Diagnostic Devices-- September 29, 1997 ODE/DCRD Do 793
Criteria for Significant Risk Investigations
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53897]]
Draft Guidance for Preparation of PMA Applications for March 16, 1993 ODE/DCRD Do 809
Testicular Prostheses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Preparation of PMA Applications for March 16, 1993 ODE/DCRD Do 810
Penile Inflatable Implants
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for the Content of Premarket May 30, 1997 ODE/DCRD Do 842
Notifications for Water Purification Components and
Systems for Hemodialysis
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Submission of Research and Marketing May 1, 1995 ODE/DCRD Do 846
Applications for Interventional Cardiology Devices:
PTCA Catheters, Atherectomy Catheters, Lasers,
Intravascular Stents; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Preclinical and Clinical November 29, 1995 ODE/DCRD Do 850
Investigations of Urethral Bulking Agents Used in the
Treatment of Urinary Incontinence
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Review of Bone Densitometer 510(k) November 9, 1992 ODE/DCRD Do 866
Submissions
--------------------------------------------------------------------------------------------------------------------------------------------------------
Battery Guidance July 12, 1993 ODE/DCRD Do 873
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Preparation of Research and Marketing August 1, 1993 ODE/DCRD Do 885
Applications for Vascular Graft Prostheses; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) Checklist for Sterile Lubricating Jelly Used With September 19, 1994 ODE/DCRD Do 892
Transurethral Surgical Instruments
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Hemodialyzer Reuse Labeling October 6, 1995 ODE/DCRD Do 899
--------------------------------------------------------------------------------------------------------------------------------------------------------
Hysteroscopes and Gynecology Laparoscopes--Submission March 27, 1996 ODE/DCRD Do 907
Guidance for a 510(k)--Includes 00192
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for the Content of Premarket July 29, 1991 ODE/DCRD Do 953
Notifications for Loop and Rollerball Electrodes for
GYN Electrosurgical Excisions
--------------------------------------------------------------------------------------------------------------------------------------------------------
Intravascular Brachytherapy--Guidance for Data to be May 24, 1996 ODE/DCRD Do 955
Submitted to the Food and Drug Administration in
Support of Investigational Device Exemption (IDE)
Applications; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Percutaneous Transluminal Coronary Angioplasty Package February 7, 1995 ODE/DCRD Do 959
Insert Template; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Coronary and Cerebrovascular Guidewire Guidance January 1, 1995 ODE/DCRD Do 964
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Implantable Cardioverter-Defibrillators; June 24, 1996 ODE/DCRD Do 965
Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Carotid Stent--Suggestions for Content of Submissions to October 26, 1996 ODE/DCRD Do 974
the Food and Drug Administration in Support of
Investigational Devices Exemption (IDE) Applications
--------------------------------------------------------------------------------------------------------------------------------------------------------
Emergency Resuscitator Guidance; Draft April 14, 1993 ODE/DCRD Do 985
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review Guidelines for Oxygen Generators and Oxygen April 14, 1993 ODE/DCRD Do 986
Equipment; Draft Document
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft 510(k) Checklist for Condom Catheters February 23, 1995 ODE/DCRD Do 991
--------------------------------------------------------------------------------------------------------------------------------------------------------
CDRH Interim Regulatory Policy for External Penile September 10, 1997 ODE/DCRD Do 992
Rigidity Devices
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53898]]
Reviewer Guidance on Face Masks and Shield for CPR; March 16, 1994 ODE/DCRD Do 996
Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
General Guidance Document: Non-Invasive Pulse Oximeter September 7, 1992 ODE/DCRD Do 997
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Peak Flow Meters for Over-the-Counter Sale June 23, 1992 ODE/DCRD Do 998
--------------------------------------------------------------------------------------------------------------------------------------------------------
510(K) Submission Requirements for Peak Flow Meters; January 13, 1994 ODE/DCRD Do 999
Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry and FDA; Guidance for Indwelling February 21, 2000 ODE/DCRD Do 1126
Blood Gas Analyzer 510(k) Submissions
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for Premarket Notification Submission January 24, 2000 ODE/DCRD Do 1157
for Nitric Oxide Delivery Apparatus, Nitric Oxide
Analyzer and Nitrogen Dioxide Analyzer; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Latex Condoms for Men--Information for 510(k) Premarket July 23, 1998 ODE/DCRD Do 1250
Notifications: Use of Consensus Standards for
Abbreviated Submissions
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Uniform Contraceptive Labeling; July 23, 1998 ODE/DCRD Do 1251
Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Cardiopulmonary Bypass Oxygenators 510(k) January 17, 2000 ODE/DCRD Do 1361
Submissions; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket Notifications for January 16, 2000 ODE/DCRD Do 177
Penile Rigidity Implants; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Federal Register Notice; Devices Used for In Vitro September 10, 1998 ODE/DCRD Do 1620
Fertilization and Related Assisted Reproduction
Procedures: Submission Guidance for a 510(k); Draft;
Availability
--------------------------------------------------------------------------------------------------------------------------------------------------------
Hysteroscopic and Laparoscopic Insufflators: Submission August 1, 1995 ODE/DCRD Do 1907
Guidance for a 510(k)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry and CDRH Reviewers--Guidance for August 7, 1998 ODE/DCRD Do 2202
the Content of Premarket Notifications for Hemodialysis
Delivery Systems; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Noise Claims in Hearing Aid Labeling; Final October 21, 1998 ODE/DCRD Do 2210
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Diagnostic ECG Guidance November 5, 1998 ODE/DCRD Do 2232
(Including Non-Alarming ST Segment Measurement); Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Cardiac Monitor Guidance November 5, 1998 ODE/DCRD Do 2233
(including Cardiotachometer and Rate Alarm); Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Harmonic Imaging With/Without November 16, 1998 ODE/DCRD Do 2234
Contrast--Premarket Notification; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Guidance for the Content of November 30, 1998 ODE/DCRD Do 2235
Premarket Notifications for Intracorporeal
Lithotripters; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Guidance for the Submission of November 20, 1998 ODE/DCRD Do 2238
Premarket Notifications for Radionuclide Dose
Calibrators; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Non-Automated Sphygmomanometer November 19, 1998 ODE/DCRD Do 2239
(Blood Pressure Cuff) Guidance; Version 1; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53899]]
Guidance for Industry--Guidance for the Submission of December 3, 1998 ODE/DCRD Do 2240
Premarket Notifications for Emission Computed
Tomography Devices and Accessories (SPECT and PET) and
Nuclear Tomography Systems; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket Notifications for February 5, 1998 ODE/DCRD Do 2243
Metal Expandable Biliary Stents; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Submission of 510(k)'s for Solid State August 6, 1999 ODE/DCRD Do 644
X-Ray Imaging Devices; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Class II Special Control Guidance Document for Acute July 30, 2000 ODE/DCRD Do 1138
Upper Airway Obstruction Devices
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Conducting Stability Testing to Support an November 16, 1999 ODE Division of Dental, Do 1355
Expiration Date Labeling Claim for Medical Gloves; Infection Control and
Draft General Hospital Devices
(DDIGD)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reprocessing and Reuse of Single-Use Devices: Review February 8, 2000 ODE/DDIGD Do 1156
Prioritization Scheme; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Premarket Approval Applications (PMA) for Sharps Needle March 2, 2001 ODE/DDIGD Do 891
Destruction Devices; Final Guidance for Industry and
FDA
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on the Content and Format of Premarket June 2, 1998 ODE/DDIGD Do 4
Notification 510(k) Submissions of Washers and Washer-
Disinfectors
--------------------------------------------------------------------------------------------------------------------------------------------------------
Overview of Information Necessary for Premarket April 21, 1999 ODE/DDIGD Do 86
Notification Submissions for Endosseous Implants; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Arrangement and Content of a Premarket May 16, 1989 ODE/DDIGD Do 353
Approval (PMA) Application for an Endosseous Implant
for Prosthetic Attachment
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on 510(k) Submissions for Implanted Infusion October 1, 1990 ODE/DDIGD Do 392
Ports
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on the Content of Premarket Notification April 1, 1993 ODE/DDIGD Do 450
[510(K)] Submissions for Hypodermic Single Lumen
Needles
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document on Dental Handpieces July 1, 1995 ODE/DDIGD Do 556
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on the Content and Format of Premarket December 6, 1996 ODE/DDIGD Do 576
Notification 510(k) Submissions for Liquid Chemical
Germicides
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on the Content of Premarket Notification April 1, 1993 ODE/DDIGD Do 821
[510(K)] Submissions for Piston Syringes
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on the Content of Premarket Notification March 1, 1993 ODE/DDIGD Do 822
[510(K)] Submissions for Clinical Electronic
Thermometers
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on the Content of Premarket Notification March 1, 1993 ODE/DDIGD Do 823
[510(k)] Submissions for External Infusion Pumps
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Premarket Notification [510(K)] Submissions March 16, 1995 ODE/DDIGD Do 824
for Short-Term and Long-Term Intravascular Catheters
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Premarket Notification [510(k)] Submissions March 1, 1993 ODE/DDIGD Do 833
for Sterilizers Intended for Use in Health Care
Facilities
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53900]]
Guidance on Premarket Notification [510(k)] Submissions August 1, 1993 ODE/DDIGD Do 881
for Automated Endoscope Washers, Washer/Disinfectors,
and Disinfectors Intended for Use in Health Care
Facilities
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Premarket Notification [510(k)] Submissions August 1, 1993 ODE/DDIGD Do 888
for Surgical Gowns and Surgical Drapes
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on the Content and Format of Premarket October 1, 1993 ODE/DDIGD Do 895
Notification [510(k)] Submissions for Sharps Containers
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Supplementary Guidance on the Content of Premarket March 1, 1995 ODE/DDIGD Do 934
Notification [510(k)] Submissions for Medical Devices
With Sharps Injury Prevention Features (Antistick)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry and FDA Reviewers/Staff--Premarket January 13, 1999 ODE/DDIGD Do 944
Notification [510(k)] Submissions for Testing for Skin
Sensitization to Chemicals in Natural Latex Products
[Draize Testing]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Information Necessary for Premarket Notification December 9, 1996 ODE/DDIGD Do 948
Submissions for Screw-Type Endossesous Implants
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance Document for the Preparation of Premarket March 3, 1997 ODE/DDIGD Do 984
Notification [510(k)'s] for Dental Alloys
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on the Content of Premarket Notification December 1, 1995 ODE/DDIGD Do 993
[510(k)] Submissions for Protective Restraints
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Premarket Notifications for Intravascular October 12, 2000 ODE/DDIGD Do 1189
Administration Sets; Guidance for Industry and FDA
Review Staff; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Addendum to: Guidance on Premarket Notification [510(k)] September 19, 1995 ODE/DDIGD Do 1833
Submissions for Sterilizers Intended for Use in Health
Care Facilities
--------------------------------------------------------------------------------------------------------------------------------------------------------
Groups Capable of Testing for Latex Skin Sensitization July 28, 1997 ODE/DDIGD Do 1944
(Addendum to #944)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry and FDA Reviewers; Neonatal and September 18, 1998 ODE/DDIGD Do 2201
Neonatal Transport Incubators--Premarket Notifications;
Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dental Impression Materials--Premarket Notification; August 17, 1998 ODE/DDIGD Do 2203
Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dental Cements Premarket Notification; Final August 18, 1998 ODE/DDIGD Do 2204
--------------------------------------------------------------------------------------------------------------------------------------------------------
OTC Denture Cushions, Pads, Reliners, Repair Kits and August 18, 1998 ODE/DDIGD Do 2205
Partially Fabricated Denture Kits; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Preparation of a Premarket Notification November 27, 1998 ODE/DDIGD Do 642
[510(k)] for Direct Filling Dental Composites
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance and Format of Premarket Notification [510(k)] January 3, 2000 ODE/DDIGD Do 397
Submissions for Liquid Chemical Sterilants/High Level
Disinfectants; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Class II Special Control Guidance Document: Pharmacy March 12, 2001 ODE/DDIGD Do 1326
Compounding Devices; Final Guidance for Industry and
FDA
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Guidance for the Content of April 28, 1998 ODE Division of General, Do 6
Premarket Notifications for Esophageal and Tracheal Restorative and
Prostheses; Final Neurological Devices
(DGRND)
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53901]]
Calcium Phosphate (Ca-P) Coating Draft Guidance for February 21, 1997 ODE/DGRND Do 33
Preparation of FDA Submissions for Orthopedic and
Dental Endosseous Implants
--------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) Information Needed for Hydroxyapatite Coated February 20, 1997 ODE/DGRND Do 47
Orthopedic Implants
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter: Core Study for Silicone Breast Implants January 11, 1996 ODE/DGRND Do 107
--------------------------------------------------------------------------------------------------------------------------------------------------------
Protocol for Dermal Toxicity Testing for Devices in January 1, 1985 ODE/DGRND Do 124
Contact With Skin (Draft)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Version 1--Biofeedback Devices--Draft Guidance for August 1, 1994 ODE/DGRND Do 143
510(k) Content
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Data Requirements for Ultrahigh Molecular Weight March 28, 1995 ODE/DGRND Do 180
Polyethylene (Uhmupe) Used in Orthopedic Devices
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance Document for Femoral Stem Prostheses August 1, 1995 ODE/DGRND Do 187
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Premarket Notification Review Guidance for Evoked June 1, 1994 ODE/DGRND Do 207
Response Somatosensory Stimulators
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Version Guide for Cortical Electrode 510(k) August 10, 1992 ODE/DGRND Do 208
Content
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Version Guidance for Clinical Data to be Submitted August 20, 1992 ODE/DGRND Do 209
for Premarket Approval Application for Cranial
Electrotherapy Stimulators
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Version Cranial Perforator Guidance July 13, 1994 ODE/DGRND Do 212
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Version Neuro Endoscope Guidance July 7, 1994 ODE/DGRND Do 214
--------------------------------------------------------------------------------------------------------------------------------------------------------
Galvanic Skin Response Measurement Devices--Draft August 1, 1994 ODE/DGRND Do 215
Guidance for 510(k) Content
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation of IDE and PMA February 18, 1993 ODE/DGRND Do 233
Applications for Intra-Articular Prosthetic Knee
Ligament Devices
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry, FDA Reviewers/Staff and June 9, 1999 ODE/DGRND Do 2246
Compliance Guidance Document for Powered Muscle
Stimulator 510(k)s; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Guidance for the Preparation of a August 30, 1999 ODE/DGRND Do 54
Premarket Notification Application for Processed Human
Dura Mater; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for TENS 510(k) Content (Draft) August 1, 1994 ODE/DGRND Do 300
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation of Premarket July 26, 1995 ODE/DGRND Do 307
Notification [510(k)] Applications for Submerged
(Underwater) Exercise Equipment
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation of Premarket July 26, 1995 ODE/DGRND Do 325
Notification [510(k)] Applications for Electromyograph
Needle Electrodes
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation of Premarket July 26, 1995 ODE/DGRND Do 326
Notification [510(k)] Applications for Exercise
Equipment
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation of Premarket July 26, 1995 ODE/DGRND Do 346
Notification [510k)] Applications for Mechanical and
Powered Wheelchairs, and Motorized Three-Wheeled
Vehicles
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53902]]
Guidance Document for the Preparation of Premarket January 10, 1995 ODE/DGRND Do 355
Notification for Ceramic Ball Hip Systems
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on the Content and Organization of a Premarket June 1, 1995 ODE/DGRND Do 386
Notification for a Medical Laser
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance Document for Testing Acetabular Cup May 1, 1995 ODE/DGRND Do 453
Prostheses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for Industry and CDRH Staff for the March 18, 1998 ODE/DGRND Do 487
Preparation of Investigational Device Exemptions and
Premarket Approval Applications for Bone Growth
Stimulator Devices; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Copy of October 9, 1992, Letter and Original Suture October 9, 1992 ODE/DGRND Do 502
Labeling Guidance (Reformatted 12/17/1997)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Alternate Suture Labeling Resulting From the January 11, January 11, 1993 ODE/DGRND Do 503
1993, Meeting With HIMA (Reformatted 12/17/1997)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidelines for Reviewing Premarket Notifications that February 1, 1997 ODE/DGRND Do 593
Claim Substantial Equivalence to Evoked Response
Stimulators
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Version--Guidance on Biocompatibility Requirements September 12, 1994 ODE/DGRND Do 627
for Long Term Neurological Implants: Part 3--Implant
Model
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Studies for Pain Therapy Devices--General May 12, 1988 ODE/DGRND Do 640
Considerations in the Design of Clinical Studies for
Pain-Alleviating Devices
--------------------------------------------------------------------------------------------------------------------------------------------------------
ORDB 510(k) Sterility Review Guidance July 3, 1997 ODE/DGRND Do 659
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for the Preparation of a Premarket August 30, 1994 ODE/DGRND Do 667
Notification for Extended Laparoscopy Devices (ELD)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Outline for a Guidance Document for Testing November 1, 1993 ODE/DGRND Do 668
Orthopedic Bone Cement, Request for Comments by
December 10, 1993
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation of Premarket July 26, 1995 ODE/DGRND Do 689
Notification [510(k)] Applications for Beds
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation of Premarket July 26, 1995 ODE/DGRND Do 729
Notification [510(k)] Applications for Immersion
Hydrobaths
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation of Premarket July 26, 1995 ODE/DGRND Do 735
Notification [510(k)] Applications for Powered Tables
and Multifunctional Physical Therapy Tables
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation of Premarket July 26, 1995 ODE/DGRND Do 762
Notification [510(k)] Applications for Communications
Systems (Powered and Non-Powered) and Powered
Environmental Control Systems
--------------------------------------------------------------------------------------------------------------------------------------------------------
Electroencephalograph Devices Guidance for 510(k) November 3, 1997 ODE/DGRND Do 767
Content; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation of Premarket July 26, 1995 ODE/DGRND Do 818
Notification [510(k)] Applications for Therapeutic
Massagers and Vibrators
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for Testing Orthopedic Implants With April 28, 1994 ODE/DGRND Do 827
Modified Metallic Surfaces Apposing Bone or Bone Cement
(Replaces 8623 and 8093)
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53903]]
Guidance Document for the Preparation of Premarket July 26, 1995 ODE/DGRND Do 828
Notification [510(k)] Applications for Heating and
Cooling Devices
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reviewers Guidance Checklist for Orthopedic External February 21, 1997 ODE/DGRND Do 829
Fixation Devices
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for the Preparation of Premarket April 1, 1993 ODE/DGRND Do 830
Notifications [510(k)]s for Cemented, Semi-Constrained
Total Knee Prostheses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance Document for the Preparation of Premarket July 16, 1997 ODE/DGRND Do 832
Notification [510(k)] Applications for Orthopedic
Devices--The Basic Elements
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft 510(k) Guideline for General Surgical May 10, 1995 ODE/DGRND Do 904
Electrosurgical Devices
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Arthroscopes and Accessory 510(k)s May 1, 1994 ODE/DGRND Do 909
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for Testing Biodegradable Polymer April 20, 1996 ODE/DGRND Do 914
Implant Devices; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for Testing Bone Anchor Devices; Draft April 20, 1996 ODE/DGRND Do 915
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for Testing Non-Articulating, May 1, 1995 ODE/DGRND Do 916
``Mechanically Locked'', Modular Implant Components;
Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reviewers Guidance Checklist for Intramedullary Rods February 21, 1997 ODE/DGRND Do 956
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Testing MR Interaction With Aneurysm May 22, 1996 ODE/DGRND Do 958
Clips
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Guidance Document for Dura August 13, 1999 ODE/DGRND Do 1152
Substitute Devices; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for Surgical Lamp 510Ks; Final July 13, 1998 ODE/DGRND Do 1244
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Guidance on Preclinical and October 5, 1999 ODE/DGRND Do 1354
Clinical Data and Labeling for Breast Prostheses; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation of IDEs for Spinal January 13, 2000 ODE/DGRND Do 2250
Systems; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for the Preparation of an IDE Submission April 4, 1995 ODE/DGRND Do 1817
for a Interactive Wound and Burn Dressing
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry and/or for FDA Reviewers/Staff and/ October 30, 1998 ODE/DGRND Do 2207
or Compliance--Guidance Document for Powered Suction
Pump 510(k)s
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Preparation of a Premarket Notification March 2, 1999 ODE/DGRND Do 2247
Application for a Surgical Mesh; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance Shoulder Joint Metal/ October 31, 2000 ODE/DGRND Do 1193
Polymer/Metal Nonconstrained or Semi-Constrained Porous-
Coated Uncemented Prosthesis; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Dermabrasion Devices; Final March 2, 1999 ODE/DGRND Do 2248
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for the Preparation of a Premarket May 31, 1995 ODE/DGRND Do 2817
Notification for a Non-Interactive Wound and Burn
Dressing [510(k)]
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53904]]
Guidance for Resorbable Adhesion Barrier Devices for Use December 16, 1999 ODE/DGRND Do 1356
in Abdominal and/or Pelvic Surgery; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Special Control Guidance for Premarket Notifications for September 6, 2000 ODE/DGRND Do 1179
Totally Implanted Spinal Cord Stimulators for Pain
Relief; Guidance for Industry; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Surgical Suture 510(k)s; Guidance for August 10, 2000 ODE/DGRND Do 1180
Industry; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Neurological Embolization Devices; Guidance November 1, 2000 ODE/DGRND Do 1151
for Industry; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Spinal System 510(k)s September 27, 2000 ODE/DGRND Do 636
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDA Guidelines for Multifocal Intraocular Lens IDE May 29, 1997 ODE Division of Do 55
Studies and PMAs Ophthalmic and Ear,
Nose, and Throat Devices
(DOED)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Announcement: Information for Manufacturers and Users of September 22, 1997 ODE/DOED Do 93
Lasers for Refractive Surgery [Excimer]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on the Content and Format of Premarket January 16, 1998 ODE/DOED Do 94
Notification [510(k)] Submissions for Surgical Mask--
Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
New FDA Recommendations and Results of Contact Lens May 30, 1989 ODE/DOED Do 265
Study (7-Day Letter)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Premarket Notification 510(k) Guidance for Contact May 1, 1997 ODE/DOED Do 674
Lens Care Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Important Information About Rophae Intraocular Lenses August 20, 1992 ODE/DOED Do 811
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Premarket Notification [510(k)] Guidance Document May 12, 1994 ODE/DOED Do 896
for Class II Daily Wear Contact Lenses and 6/28, 1994,
Corrections to Pages 18 and 20
--------------------------------------------------------------------------------------------------------------------------------------------------------
Retinoscope Guidance; Final July 8, 1998 ODE/DOED Do 1240
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Ophthalmoscope Guidance (Direct July 8, 1998 ODE/DOED Do 1241
and Indirect)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Slit Lamp Guidance; Final July 13, 1998 ODE/DOED Do 1242
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry and FDA Staff--Revised Procedures August 11, 1998 ODE/DOED Do 1249
for Adding Lens Finishing Laboratories to Approved
Premarket Approval (PMA) Applications for Class III
Rigid Gas Permeable Contact Lenses for Extended Wear;
Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Accountability Analysis for Clinical Studies for August 4, 1999 ODE/DOED Do 1350
Ophthalmic Devices; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on 510(k) Submissions for Keratoprostheses; March 3, 1999 ODE/DOED Do 1351
Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Amendment 1: Draft Premarket Notification [510(k)] June 28, 1994 ODE/DOED Do 1896
Guidance Document for Class II Daily Wear Contact
Lenses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Checklist of Information Usually Submitted in an October 10, 1996 ODE/DOED Do 2093
Investigational Device Exemptions (IDE) Application for
Refractive Surgery Lasers [Excimer]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Third Party Review Guidance for Vitreous Aspiration and January 31, 1997 ODE/DOED Do 2196
Cutting Device Premarket Notification [510(k)]
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53905]]
Guidance Document for Nonprescription Sunglasses; Final October 9, 1998 ODE/DOED Do 2208
--------------------------------------------------------------------------------------------------------------------------------------------------------
Aqueous Shunts--510(k) Submissions; Final November 16, 1998 ODE/DOED Do 2236
--------------------------------------------------------------------------------------------------------------------------------------------------------
Discussion Points for Expansion of the ``Checklist of September 5, 1997 ODE/DOED Do 7093
Information Usually Submitted in an Investigational
Device Exemption (IDE) Application for Refractive
Surgery Lasers'' Draft Document
--------------------------------------------------------------------------------------------------------------------------------------------------------
Intraocular Lens (IOL) Guidance Document; Draft October 14, 1999 ODE/DOED Do 834
--------------------------------------------------------------------------------------------------------------------------------------------------------
Refractive Implants: Guidance for Investigational Device August 1, 2000 ODE/DOED Do 1145
Exemptions (IDE) and Premarket Approval (PMA)
Applications
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Premarket Submissions of Orthokeratology April 10, 2000 ODE/DOED Do 1134
Rigid Gas Permeable Contact Lenses; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Manufacturers Seeking Marketing Clearance March 12, 2000 ODE/DOED Do 954
of Ear, Nose, and Throat Endoscope Sheaths Used as
Protective Barriers; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Information for a Latex Condom 510(k) Submission for April 13, 1994 ODE Division of Do 398
Obstetrics-Gynecology Devices Branch--Draft Reproductive, Abdominal,
and Radiological Devices
(DRARD)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket Notifications for June 7, 1994 ODE/DRARD Do 96
Urine Drainage Bags
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft--510(k) Checklist for Conditioned Response November 23, 1994 ODE/DRARD Do 99
Enuresis Alarms
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Preparation of PMA Applications for May 1, 1995 ODE/DRARD Do 161
the Implanted Mechanical/Hydraulic Urinary Continence
Device (Artificial Urinary Sphincter)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for the Content of Premarket March 17, 1995 ODE/DRARD Do 162
Notifications for Endoscopes Used in Gastroenterology
and Urology
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for the Content of Premarket May 25, 1995 ODE/DRARD Do 166
Notifications for Menstrual Tampons
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft 510(k) Checklist for Non-Implanted Electrical June 6, 1995 ODE/DRARD Do 189
Stimulators Used for the Treatment of Urinary
Incontinence
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft 510(k) Checklist for Endoscopic Light Sources Used June 22, 1995 ODE/DRARD Do 190
in Gastroenterology and Urology
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance (``Guidelines'') for Evaluation of Laparoscopic May 1, 1978 ODE/DRARD Do 232
Bipolar and Thermal Coagulators (and Accessories)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance (``Guidelines'') for Evaluation of Fetal Clip March 8, 1977 ODE/DRARD Do 244
Electrode
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance (``Guidelines'') for Evaluation of Tubal November 22, 1977 ODE/DRARD Do 245
Occlusion Devices
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance (``Guidelines'') for Evaluation of May 10, 1978 ODE/DRARD Do 248
Hysteroscopic Sterilization Devices
--------------------------------------------------------------------------------------------------------------------------------------------------------
Intrapartum Continuous Monitors for Fetal Oxygen June 14, 1997 ODE/DRARD Do 298
Saturation and Fetal pH; Submission Guidance for a PMA;
Draft Document
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53906]]
Guidance for the Arrangement and Content of a Premarket May 1, 1990 ODE/DRARD Do 327
Approval (PMA) Application For A Cochlear Implant in
Children Ages 2 Through to 17 Years
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Guidance for the Submission of November 14, 1998 ODE/DRARD Do 340
Premarket Notifications for Magnetic Resonance
Diagnostic Devices; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Premarket Testing Guidelines for Female Barrier April 4, 1990 ODE/DRARD Do 384
Contraceptive Devices Also Intended to Prevent Sexually
Transmitted Diseases
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft of Suggested Information for Reporting January 18, 1991 ODE/DRARD Do 418
Extracorporeal Shock Wave Lithotripsy Device Shock Wave
Measurements
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket Notifications for August 7, 1998 ODE/DRARD Do 421
Conventional and Permeability Hemodialyzers; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket Notifications for February 10, 1993 ODE/DRARD Do 431
Urethral Stents
--------------------------------------------------------------------------------------------------------------------------------------------------------
Testing Guidance for Male Condoms Made From New Material June 29, 1995 ODE/DRARD Do 455
(Non-Latex)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket Notifications for February 10, 1993 ODE/DRARD Do 482
Biopsy Devices Used in Gastroenterology and Urology
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket Notifications for July 29, 1994 ODE/DRARD Do 490
Urodynamic/Uroflowmetry Systems
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Investigational Device Exemptions for January 16, 2001 ODE/DRARD Do 1164
Solutions for Hypothermic Flushing, Transport, and
Storage of Organs for Transplantation; Final Guidance
for Industry and FDA Reviewers
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Submission of Premarket Notifications July 27, 2000 ODE/DRARD Do 416
for Medical Image Management Devices; Guidance for
Industry; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket Notifications August 9, 2000 ODE/DRARD Do 1226
(510(k)s) for Extracorporeal Shock Wave Lithotripters
Indicated for the Fragmentation of Kidney and Ureteral
Calculi; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Submission of Premarket Notifications August 2, 2000 ODE/DRARD Do 1177
for Photon-Emitting Brachytherapy Sources; Guidance for
Industry; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Premarket Applications for Digital Mammography Systems; February 16, 2001 ODE/DRARD Do 983
Final Guidance for Industry and FDA
--------------------------------------------------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance for Home Uterine March 9, 2001 ODE/DRARD Do 820
Activity Monitors; Final Guidance for Industry and FDA
Reviewers
--------------------------------------------------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance Document for Clitoral July 3, 2000 ODE/DRARD Do 1144
Engorgement Devices; Guidance for Industry and FDA
Reviewers
--------------------------------------------------------------------------------------------------------------------------------------------------------
Thermal Endometrial Ablation Devices (Submission March 14, 1996 ODE/DRARD Do 547
Guidance for an IDE); Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for the Clinical Investigation of November 2, 1995 ODE/DRARD Do 573
Urethral Stents
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53907]]
Tympanostomy Tubes Submission Guidance for a 510(k) January 14, 1998 ODE/DRARD Do 930
Premarket Notification; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Early Collaboration Meetings Under the FDA Modernization February 28, 2001 ODE Program Operations Do 310
Act (FDAMA); Final Guidance for Industry and for CDRH Staff (POS)
Staff
--------------------------------------------------------------------------------------------------------------------------------------------------------
PMA/510(k) Expedited Review #G98-4 (Blue Book Memo) March 20, 1998 ODE/POS Do 7
--------------------------------------------------------------------------------------------------------------------------------------------------------
PMA/510(k) Expedited Review--Guidance for Industry and March 20, 1998 ODE/POS Do 108
CDRH Staff [FDAMA]; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Deciding When to Submit a 510(k) for a Change to an January 10, 1997 ODE/POS Do 935
Existing Device
--------------------------------------------------------------------------------------------------------------------------------------------------------
A Suggested Approach to Resolving Least Burdensome September 11, 2000 ODE/POS Do 1188
Issues
--------------------------------------------------------------------------------------------------------------------------------------------------------
Suggested Format for Developing and Responding to November 2, 2000 ODE/POS Do 1195
Deficiencies in Accordance with the Least Burdensome
Provisions of FDAMA; Final; Guidance for Industry and
FDA Staff
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDA Modernization Act of 1997 Guidance for the Device February 6, 1998 Office of Health and Do 434
Industry on Implementation of Highest Priority Industry Programs (OHIP)
Provisions [FDAMA]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Accidental Radioactive Contamination of Human Food and August 13, 1998 OHIP Do 1071
Animal Feeds: Recommendations to State and Local
Agencies
--------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Guidance--The Mammography Quality Standards May 5, 1999 OHIP Division of Do 6400
Act Final Regulations--Preparing for MQSA Inspections Mammography Quality and
Radiation Programs
(DMQRP)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Submission of Request for Reconsideration March 26, 1998 OHIP/DMQRP Do 69
of Adverse Decisions on Accreditation of Mammography
Facilities Under the Mammography Quality Standards
Acts, 42 U.S.C. 263(b)/4/8, 1998
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Review of Requests for Reconsideration of March 26, 1998 OHIP/DMQRP Do 83
Adverse Decisions on Accreditation of Mammography
Facilities Under the Mammography Quality Standards Act,
42 U.S.C. 263(b)/4/8, 1998
--------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Guidance; The Mammography Quality Standards September 13, 2000 OHIP/DMQRP Do 1159
Act Final Regulations Document #4; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
The Mammography Quality Standards Act Final Regulations; January 24, 2001 OHIP/DMQRP Do 1317
Modifications and Additions to Policy Guidance Help
System #2; Final Guidance for Industry and FDA
(Incorporated into PGHS)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Guidance: The Mammography Quality Standards December 8, 1999 OHIP/DMQRP Do 1496
Act Final Regulations Document #3 (Incorporated into
PGHS)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance: The Mammography Quality Standards Act Final March 4, 1999 OHIP/DMQRP Do 1499
Regulations Document #1 (Incorporated into PGHS)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Policy and Standard Operating Procedures When April 15, 1998 OHIP/DMQRP Do 1186
Mammography Facilities in States That Have
Accreditation Bodies Intend to Change Accreditation
Bodies
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53908]]
Guidance for Request and Issuance of Interim Notice May 4, 1999 OHIP/DMQRP Do 2217
Letters for Mammography Facilities Under the
Mammography Quality Standards Act, 42 U.S.C. Section
263(b)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Continuing Education Credit for Reading/Writing Articles/ March 17, 1998 OHIP/DMQRP Do 66206
Papers and Presenting Courses/Lectures (Incorporated
into PGHS)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Requalification for Interpreting May 28, 1998 OHIP/DMQRP Do 66301
Physician's Continuing Experience Requirement
(Incorporated into PGHS)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Guidance: The Mammography Quality Standards March 23, 1999 OHIP/DMQRP Do 2256
Act Final Regulations Motion of Tube-Image Receptor
Assembly (Incorporated into PGHS)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Guidance: The Mammography Quality Standards December 7, 1999 OHIP/DMQRP Do 1194
Act Final Regulations Quality Assurance Documentation
(Incorporated into PGHS)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Guidance: The Mammography Quality Standards February 25, 2000 OHIP/DMQRP Do 1498
Act Final Regulations Document #2 (Incorporated into
PGHS)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Guidance--Mammography Facility Survey, November 6, 2000 OHIP/DMQRP Do 6409
Equipment Evaluation and Medical Physicist
Qualification Requirements Under MQSA; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medical Glove Guidance Manual Draft FDA 99-4257 August 12, 1999 OHIP Division of Small Do 852
Manufacturers Assistance
(DSMA)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Instructions for Completion of Medical Device July 1, 1997 OHIP/DSMA Do 12
Registration and Listing Forms FDA 2891, 2891a and 2892
--------------------------------------------------------------------------------------------------------------------------------------------------------
An Introduction to Medical Device Regulations (FDA 92- January 1, 1992 OHIP/DSMA Do 18
4222)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulatory Requirements for Devices for the Handicapped August 1, 1987 OHIP/DSMA Do 22
(FDA 87-4221)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Impact Resistant Lenses: Questions and Answers (FDA 87- September 1, 1987 OHIP/DSMA Do 23
4002)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Comparison Chart: 1996 Quality System Reg vs. 1978 Good November 29, 1996 OHIP/DSMA Do 133
Manufacturing Practices Reg vs. ANSI/ISO/ASQC Q9001 and
ISO/DI 13485:1996 (Include 126)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medical Device Appeals and Complaints: A Guidance on February 19, 1998 OHIP/DSMA Do 396
Dispute Resolution
--------------------------------------------------------------------------------------------------------------------------------------------------------
Premarket Notification: 510(k)--Regulatory Requirements August 1, 1995 OHIP/DSMA Do 469
for Medical Devices (FDA 95-4158) [Available on Disk]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Labeling--Regulatory Requirements for Medical Devices September 1, 1989 OHIP/DSMA Do 470
(FDA 89-4203)
--------------------------------------------------------------------------------------------------------------------------------------------------------
In Vitro Diagnostic Devices: Guidance for the January 1, 1997 OHIP/DSMA Do 471
Preparation of 510(k) Submissions (FDA 97-4224)
[Available on Disk]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Investigational Device Exemptions [IDE] Manual (FDA 96- June 1, 1996 OHIP/DSMA Do 472
4159) DSMA [Available on Disk]
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53909]]
Regulation of Medical Devices; Background Information April 14, 1999 OHIP/DSMA Do 610
for International Officials (Entire Document Available
on Disk)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medical Device Reporting for Manufacturers [Available on March 1, 1997 OHIP/DSMA Do 987
Disk]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Premarket Approval (PMA) Manual January 1, 1998 OHIP/DSMA Do 1051
--------------------------------------------------------------------------------------------------------------------------------------------------------
Overview of FDA Modernization Act of 1997 Medical Device February 19, 1998 OHIP/DSMA Do 1174
Provisions [FDAMA]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Mutual Recognition Agreement Between the European Union June 29, 2000 OHIP/DSMA Do 1175
and the United States of America: Confidence Building
Programme: Overview and Procedure; Medical Device
Annex, Version 7, June 29, 2000; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Implementation of Third Party Programs Under the FDA February 2, 2001 OHIP/DSMA Do 1160
Modernization Act of 1997; Final Guidance for Staff,
Industry and Third Parties
--------------------------------------------------------------------------------------------------------------------------------------------------------
CDRH Manual for the Good Guidance Practices (GGP) February 9, 2001 OHIP Division of Device Do 1323
Regulations; Final Guidance for FDA Staff User Programs and
Systems Analysis (DUPSA)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Human Factors Principles for Medical Device Labeling September 1, 1993 OHIP/DUPSA Do 227
--------------------------------------------------------------------------------------------------------------------------------------------------------
Human Factors Points to Consider for IDE Devices January 17, 1997 OHIP/DUPSA Do 839
--------------------------------------------------------------------------------------------------------------------------------------------------------
Write It Right August 1, 1993 OHIP/DUPSA Do 897
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medical Device Reporting for User Facilities April 1, 1996 OHIP/DUPSA Do 989
--------------------------------------------------------------------------------------------------------------------------------------------------------
Do It By Design--An Introduction to Human Factors in December 1, 1996 OHIP/DUPSA Do 995
Medical Devices
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medical Device Use--Safety: Incorporating Human Factors July 18, 2000 OHIP/DUPSA Do 1497
Engineering into Risk Management; Guidance for Industry
and FDA Premarket and Design Control Reviewers
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Medical Device Patient Labeling; Final April 19, 2001 OHIP/DUPSA Do 1128
Guidance for Industry and FDA Reviewers
--------------------------------------------------------------------------------------------------------------------------------------------------------
Perspectives on Clinical Studies for Medical Device Office of Surveillance Do 78
Submissions (Statistical) and Biometrics (OSB)
Division of
Biostatistics (DB)
--------------------------------------------------------------------------------------------------------------------------------------------------------
PMA Review Statistical Checklist (no date available) OSB/DB Do 84
--------------------------------------------------------------------------------------------------------------------------------------------------------
Statistical Aspects of Submissions to FDA: A Medical June 1, 1984 OSB/DB Do 537
Device Perspective (Also Includes as Appendix the
Article Observed Uses and Abuses of Statistical
Procedures in Medical Device Submissions
--------------------------------------------------------------------------------------------------------------------------------------------------------
MDR Guidance Document: Remedial Action Exemption-- July 30, 1996 OSB/DSS Do 188
E1996001; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Adverse Event Reporting for Hospitals That April 24, 2001 OSB/DSS Do 1334
Reprocess Devices Intended by the Originial Equipment
Manufacturer for Single Use
--------------------------------------------------------------------------------------------------------------------------------------------------------
MDR Guidance Document No. 1-IOL-E1996004; Final August 7, 1996 OSB/DSS Do 216
--------------------------------------------------------------------------------------------------------------------------------------------------------
MDR Guidance Document No. 3--Needlestick and Blood August 9, 1996 OSB/DSS Do 250
Exposure--E1996003; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53910]]
Common Problems: Baseline Reports and Medwatch Form January 1, 1997 OSB/DSS Do 379
3500A
--------------------------------------------------------------------------------------------------------------------------------------------------------
MDR Reporting Guidance for Breast Implants--E1996002; August 7, 1996 OSB/DSS Do 452
Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medical Device Reporting: An Overview; Final April 1, 1996 OSB/DSS Do 509
--------------------------------------------------------------------------------------------------------------------------------------------------------
Instructions for Completing FDA Form 3500A With Coding December 15, 1995 OSB/DSS Do 853
Manual for Form 3500A (MEDWATCH)(MDR); Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
MEDWATCH FDA Form 3500A for Use by User Facilities, June 1, 1993 OSB/DSS Do 854
Distributors and Manufacturers for Mandatory Reporting
(MDR); Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Variance From Manufacturer Report Number Format [MDR July 16, 1996 OSB/DSS Do 1059
Letter]; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Instructions for Completing Form 3417: Medical Device March 31, 1997 OSB/DSS Do 1061
Reporting Baseline Report [MDR]; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
MDR Internet List Server (listserv) Instruction Sheet; August 29, 1996 OSB/DSS Do 1094
Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medical Device Reporting-Alternative Summary Reporting October 19, 2000 OSB/DSS Do 315
(ASR) Program; Guidance for Industry
--------------------------------------------------------------------------------------------------------------------------------------------------------
Addendum to the Instructions for Completing FDA Form June 9, 1999 OSB/DSS Do 1853
3500A With Coding Manual (MEDWATCH) (MDR); Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance to Sponsors on the Development of a June 9, 1993 OSB Issues Management Do 206
Discretionary Postmarket Surveillance Study for Staff (IMS)
Permanent Implantable Cardiac Pacemaker Electrodes
(Leads)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Criteria and Approaches for Postmarket November 2, 1998 OSB/IMS Do 9
Surveillance
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Procedures to Determine Application of February 19, 1998 OSB/IMS Do 316
Postmarket Surveillance Strategies [FDAMA]; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Procedures for Review of Postmarket February 19, 1998 OSB/IMS Do 317
Surveillance Submissions [FDAMA]; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry and FDA Staff--SMDA to FDAMA: November 2, 1998 OSB/IMS Do 318
Guidance on FDA's Transition Plan for Existing
Postmarket Surveillance Protocols [FDAMA]; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Amendment to Guidance on Discretionary Postmarket March 30, 1994 OSB/IMS Do 374
Surveillance on Pacemaker Leads; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry on the Testing of Metallic Plasma February 2, 2000 OSB/IMS Do 946
Sprayed Coatings on Orthopedic Implants to Support
Reconsideration of Postmarket
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Frequently Asked Questions on Recognition of December 21, 1998 Office of Science and Do 109
Consensus Standards [FDAMA] Technology (OST)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on the Recognition and Use of Consensus February 19, 1998 OST Do 321
Standards/Appendix A [FDAMA]
--------------------------------------------------------------------------------------------------------------------------------------------------------
A Primer on Medical Device Interactions With Magnetic February 7, 1997 OST Do 952
Resonance Imaging Systems; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
CDRH Standard Operating Procedures for the August 6, 1999 OST Do 616
Identification and Evaluation of Candidate Consensus
Standard for Recognition
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53911]]
Guidance on FDA's Expectations of Medical Device May 15, 1998 OST Do 2000
Manufacturers Concerning the Year 2000 Date Problems
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry and FDA Reviewers: Guidance on May 6, 1999 OST Division of Life Do 635
Immunotoxicity Testing Sciences (DLS)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Withdrawals
--------------------------------------------------------------------------------------------------------------------------------------------------------
Intended User or
Name of Document Date of Issuance Regulatory Activity Date of Withdrawal FOD No.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry and for FDA Staff: Enforcement February 8, 2000 OC August 8, 2000 801029
Priorities for Single-Use Devices Reprocessed by Third
Parties and Hospitals, Draft Guidance--Not for
Implementation (Replaced by Enforcement Priorities for
Single-Use Devices Reprocessed by Third Parties and
Hospitals; Guidance for Industry and for FDA Staff 8/14/
00)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Information Disclosure by Manufacturers to October 18, 1999 OC/DOEI March 30, 2001 802619
Assemblers for Diagnostic X-Ray Systems; Guidance for
Industry (Replaced by Information Disclosure by
Manufacturers to Assemblers for Diagnostic X-Ray
Systems; Final Guidance for Industry and FDA 4/2/01)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Final Design Control Report and Guidance (No June 1, 1998 OC/DOEIII July 24, 2000 800949
Replacement)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Working Draft of the Current Good Manufacturing Practice July 1, 1995 OC/OT April 24, 2000 800303
(CGMP) Final Rule (No Replacement)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Amended Procedures for Advisory Panel January 26, 1999 ODE August 4, 2000 800413
Meetings [FDAMA]; Final (Replaced by Guidance on
Amended Procedures for Advisory Panel Meetings, 7/22/
00)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of Antimicrobial May 31, 1991 ODE/DCLD June 16, 2000 800631
Susceptibility Devices (Replaced by Guidance on Review
Criteria for Assessment of Antimicrobial Susceptibility
Devices, 3/8/00)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Premarket Submissions for Kits for December 30, 1998 ODE/DCLD October 30, 2000 802209
Screening Drugs of Abuse to Be Used by the Consumer;
Guidance for Industry; Draft (Replaced by Over-the-
Counter (OTC) Screening Tests for Drugs of Abuse:
Guidance for Premarket Notifications; Guidance for
Industry; Draft 11/14/00)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for Vascular Prostheses 510(k) November 1, 2000 ODE/DCRD January 16, 2000 801357
Submission; Final (Replaced by Guidance Document for
Vascular Prostheses 510(k) Submissions; Guidance for
Industry and FDA Staff; Final 11/1/00)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance to Manufacturers on the Development of Required Date not available ODE/DCRD June 15, 2000 800202
Postapproval Epidemiological Study Protocols for
Testicular Implants (No Replacement)
--------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) Reviewer Guidelines--Tracheostomy Tubes 868.5800 Date not available ODE/DCRD June 15, 2000 800550
(No Replacement)
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53912]]
Guidance for the Comment and Review of 510(k) August 1, 1993 ODE/DCRD August 8, 2000 800416
Notifications for Picture Archiving and Communications
Systems (PACS) and Related Devices (Replaced by
Guidance for the Submission of Premarket Notifications
for Medical Image Management Devices; Guidance for
Industry; Final 7/27/00)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Guidance for the Content of February 8, 1999 ODE/DCRD August 10, 2000 801226
Premarket Notifications [510(k)s] for Extracorporeal
Shock Wave Lithotripters Indicated for the
Fragmentation of Kidney and Ureteral Calculi (Replaced
by Guidance for the Content of Premarket Notifications
(510(k)s) for Extracorporeal Shock Wave Lithotripters
Indicated for the Fragmentation of Kidney and Ureteral
Calculi; Final 8/9/00)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Oxygen Conserving Device 510(k) Review 73 February 1, 1989 ODE/DCRD August 30, 2000 800583
BZD 868.5905 Non-continuous Ventilator Class II (No
Replacement)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reviewer's Guidance for Oxygen Concentrator (No August 30, 1991 ODE/DCRD August 30, 2000 800781
Replacement)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for Vascular Prostheses 510(k) November 26, 1999 ODE/DCRD November 16, 2000 801357
Submission; Final (Replaced by Guidance Document for
Vascular Prostheses 510(k) Submissions; Guidance for
Industry and FDA Staff; Final 11/1/00)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Submission of Research and Marketing January 14, 2000 ODE/DCRD January 21, 2000 800372
Applications for Permanent Pacemaker Leads and for
Pacemaker Lead Adaptor 510(k) Submissions; Final
(Replaced by Guidance for the Submission of Research
and Marketing Applications for Permanent Pacemaker
Leads and for Pacemaker Lead Adaptor 510(k)
Submissions; Final 11/1/00)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Information on Clinical Safety and February 5, 1992 ODE/DCRD January 10, 2001 800864
Effectiveness Data for Extracorporeal Shock Wave
Lithotripsy of Upper Urinary Tract (Renal Pelvis, Renal
Calyx and Upper Ureteral) Calculi (Replaced by Guidance
for the Content of Premarket Notifications (510(k)s)
for Extracorporeal Shock Wave Lithotripters Indicated
for the Fragmentation of Kidney and Ureteral Calculi;
Final 8/9/00)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Annuloplasty Rings 510(k) Submissions; November 26, 1999 ODE/DCRD February 12, 2001 801358
Final (Replaced by Guidance for Annuloplasty Rings
510(k) Submissions; Final Guidance for Industry and FDA
Staff 1/31/01)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Home Uterine Activity Monitors: Guidance for the July 30, 1999 ODE/DCRD March 2001 800820
Submission of 510(k) Premarket Notifications (Replaced
by Class II Special Controls Guidance for Home Uterine
Activity Monitors; Final Guidance for Industry and FDA
Reviewers, 3/9/01)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Status Update--Information for Manufacturers Seeking February 4, 1999 ODE/DCRD February 27, 2001 800983
Marketing Clearance of Digital Mammography Systems
(Replaced by Premarket Applications for Digital
Mammography Systems; Final Guidance for Industry and
FDA 2/16/01)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on the Content and Format of Premarket October 1, 1993 ODE/DDIGD August 10, 2000 800902
Notification [510(k)] Submissions for General Purpose
Disinfectants (includes Addendum of 3/9, 1994) (No
Replacement)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Preparation of Premarket Notification April 1, 1991 ODE/DDIGD September 1, 2000 800028
[510(k)] for Resorbable Periodontal Barriers (No
Replacement)
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53913]]
Guidance for Spinal System 510(k); Final (Replaced by May 7, 1999 ODE/DGRND October 2, 2000 800636
Guidance for Spinal System 510(k)s 9/27/00)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Guidance Document for August 13, 1999 ODE/DGRND November 7, 2000 801151
Neurological Embolization Devices; Final (Replaced by
Guidance for Neurological Embolization Devices;
Guidance for Industry; Final 11/1/00)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Ophthalmic Device Triage (No Replacement) March 19, 1998 ODE/DOED June 20, 2000 800160
--------------------------------------------------------------------------------------------------------------------------------------------------------
Announcement by Dr Alpert at 7/26, 1996, Ophthalmic August 26, 1996 ODE/DOED July 17, 2000 803093
Panel Meeting Concerning Manufacturers and Users of
Lasers for Refractive Surgery [Excimer] (No
Replacement)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Owners Certification of Lasers as PMA Approved Devices September 26, 1996 ODE/DOED July 17, 2000 804093
[Excimer] (No Replacement)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Guidance--Mammography Facility Survey and May 5, 1999 OHIP/DMORP April 8, 2000 806409
Medical Physicist Qualification Requirements Under MQSA
(Replaced by Compliance Guidance--Mammography Facility
Survey and Medical Physicist Qualification Requirements
Under MQSA; Final 11/6/00)
--------------------------------------------------------------------------------------------------------------------------------------------------------
A Pocket Guide to Device GMP Inspections--Inspections of November 1, 1991 OHIP/DSMA June 28, 2000 800508
Medical Device Manufacturers and GMP Regulation
Requirements (No Replacement)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Staff, Industry, and Third Parties June 12, 2000 OHIP/DSMA February 2, 2001 801160
Implementation of Third Party Programs Under the FDA
Modernization Act of 1997--June 2000; Draft (Replaced
by Implementation of Third Party Programs Under the FDA
Modernization Act of 1997; Final Guidance for Staff,
Industry and Third Parties 2/2/01)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Device Use Safety: Incorporating August 3, 1999 OHIP/DUPSA July 20, 2000 801497
Human Factors in Risk Management (No Replacement)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Medical Device Patient Labeling; Final March 3, 2000 OHIP/DUPSA April 9, 2001 801128
Guidance for Industry (Replaced by Guidance on Medical
Device Patient Labeling; Final Guidance for Industry
and FDA Reviewers 4/19/01)
--------------------------------------------------------------------------------------------------------------------------------------------------------
MDR Documents Access Information for National Technical May 10, 1996 OSB June 28, 2000 803799
Information Service (NTIS) (No Replacement)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Proposed Draft Guidance to Sponsors Regarding Required October 7, 1994 OSB/DPS June 16, 2000 800323
Postmarket Surveillance Studies of Plasma-Sprayed
Porous-Coated Hip Prostheses (Archived by OSB--Replaced
by Guidance Testing Metallic Plasma Sprayed Orthopedic
Implants, 2/2/00)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter to Manufacturers: Summary Reporting Approval for July 31, 1997 OSB/DSS October 30, 2000 800315
Adverse Events; Final (Replaced by Medical Device
Reporting--Alternative Summary Reporting (ASR) Program;
Guidance for Industry 10/19/00)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Thermal Endometrial Ablation Devices (Submission March 14, 1996 ODE/DCRD March 1996 800547
Guidance for an IDE) (Replaced by Thermal Endometrial
Ablation Devices (Submission Guidance for an IDE);
Final 3/14/96))
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Review of Cases of Possible Suspension or March 26, 1998 OHIP/DMORP May 23, 2001 800080
Revocation of Mammography Facility Certificates Under
the Mammography Quality Standards Act, 42 U.S.C. 263(b)/
4/8, 1998 (No Replacement)
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53914]]
Compliance Guidance--Mammography Facility Survey and May 5, 1999 OHIP/DMORP November 8, 2000 806409
Medical Physicist Qualification Requirements Under MQSA
, Draft (replaced by Compliance Guidance--Mammography
Facility Survey and Medical Physicist Qualification
Requirements Under MQSA; Final 11/6/00
--------------------------------------------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------------------------------------------
V. Guidance Documents Issued by the Center for Food Safety and Applied Nutrition (CFSAN)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
How to Obtain A Hard Copy of the Document (Name and Address,
Name of Document Date of Issuance Intended User or Regulatory Activity Phone, Fax, E-Mail or Internet)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Policy Guides Manual 1998 FDA Regulated Industries National Technical Information Service (NTIS), 5285 Port
Royal Rd., Springfield, VA 22161, NTIS Order No. PB96-
920500
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Programs Guidance Manual 1995 FDA Regulated Industries Do (NTIS Order No. PB95-915499
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
FDA Recall Policy 1995 FDA Regulated Industries Industry Activities Staff (HFS-565), Center for Food Safety
and Applied Nutrition, FDA, 200 C St. SW., Washington, DC
20204
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Investigators' Operations Manual May 1996 FDA Regulated Industries National Technical Information Service (NTIS), 5285 Port
Royal Rd., Springfield, VA 22161, (NTIS Order No. PB-95-
913399)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Regulatory Procedures Manual August 1995 FDA Regulated Industries Do (NTIS Order No. PB95-265534)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Requirements of Laws and Regulations Enforced by the 1997 FDA Regulated Industries Superintendent of Documents, Government Printing Office,
U.S. Food and Drug Administration ``Blue Book'' Washington, DC 20402
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Action Levels for Poisonous or Deleterious Substances 1995 Food and Animal Feed Industries Industry Activities Staff (HFS-565), Center for Food Safety
in Human Food and Animal Feed and Applied Nutrition, FDA, 200 C St. SW., Washington, DC
20204, (NTIS Order No. PB96-920500)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Pesticides Analytical Manual 1996 Food Industry National Technical Information Service (NTIS), 5285 Port
Royal Rd., Springfield, VA 22161, (NTIS Order No. PB94-
911899)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
FDA Advisory for Deoxynivanol (DON) in Finished September 16, 1993 Food and Animal Feed Industries Office of Plant and Dairy Foods and Beverages, Food and Drug
Wheat Products Intended for Human Consumption and in Administration (HFS-306), 200 C St. SW., Washington, DC
Grain and Grain By-Products for Animal Feed 20204, 202-205-4681
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
FDA's Cosmetic Labeling Manual October 1991 Cosmetic Industry Food and Drug Administration, Office of Colors and Cosmetics
(HFS-105), 200 C St. SW., Washington, DC 20204, 202-205-
4493
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Statement of Policy: Foods Derived From New Plant May 29, 1992 Developers of New Plant Food Varieties Office of Premarket Approval, Food and Drug Administration
Varieties: Notice (HFS-200), 200 C St. SW., Washington, DC 20204, 202-418-
3100
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
A Food Labeling Guide May 1997 Food Industry Industry Activities Staff (HFS-565), Center for Food Safety
and Applied Nutrition, FDA, 200 C St. SW., Washington, DC
20204, 202-205-5251
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Model Small Business Food Labeling Exemption Notice 1998 Food Industry Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Food Labeling: Questions and Answers August 1994 Food Industry Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53915]]
Food Labeling: Questions and Answers: Volume II February 1996 Food Industry Superintendent of Documents, Government Printing Office,
Washington, DC 20420, 202-512-1800
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Fair Packaging and Labeling Act Manual June 1978 Food Industry National Technical Information Service (NTIS), 5285 Port
Royal Rd., Springfield, VA 22161, 703-487-4650, (NTIS Order
No. PB-83-222117)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Bacteriological Analytical Manual 7th Edition 1992 FDA Regulated Industries AOAC International, 481 N. Frederick Ave., suite 500,
Gaithersburg, MD 20877-2417, 301-924-7077
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
FDA Food Importer's Guide for Low-Acid Canned and 1985 Food Industry Industry Activities Staff (HFS-565), Center for Food Safety
Acidified Foods and Applied Nutrition, FDA, 200 C St. SW., Washington, DC
20204, 202-205-5251
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Evaluation of Milk Laboratories 1995 States Milk Safety Branch (HFS-626), Center for Food Safety and
Applied Nutrition, 200 C St. SW., Washington, DC 20204, 202-
205-9175
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Methods of Making Sanitation Ratings of Milk Supplies 1999 States Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Dry Milk Ordinance 1995 States Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Procedures Governing the Cooperative State-Public 1999 Dairy Industry Do
Health Service/Food and Drug Administration Program
for Certification of Interstate Milk Shippers
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Frozen Dessert Processing Guidelines 1989 Dairy Industry Office of Plant and Dairy Foods and Beverages (HFS-302),
Center for Food Safety and Applied Nutrition, 200 C St.
SW., Washington, DC 20204, 202-205-9175
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Pasteurized Milk Ordinance 1999 States Milk Safety Branch (HFS-626), Center for Food Safety and
Applied Nutrition, 200 C St. SW., Washington, DC 20204, 202-
205-9175
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidelines for Determining Metric Equivalents of October 1, 1993 Food Industry Office of Nutritional Products, Labeling, and Dietary
Household Measures Supplements, Food and Drug Administration (HFS-800), 200 C
St. SW., Washington, DC 20204, 202-205-4561
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
List of Food Defect Action Levels (DALs) 1995 Food and Animal Feed Industries Industry Activities Staff (HFS-565), Center for Food Safety
and Applied Nutrition, FDA, 200 C St. SW., Washington, DC
20204, 202-205-5251
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Action Levels for Poisonous or Deleterious Substances 1995 Food and Animal Feed Industries Do
in Human Food and Feed (Also Found in CPGs)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
FDA Food Code 1999 States National Technical Information Service (NTIS), 5285 Port
Royal Rd., Springfield, VA 22161, 703-487-4650
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Seafood List 1993 Seafood Industry Superintendent of Documents, Government Printing Office,
Washington, DC 20402, 202-512-1800
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Manual of Operations National Shellfish Sanitation 1992 States Office of Seafood (HFS-407), Shellfish Sanitation Branch,
200 C St. SW., Washington, DC 20204, 202-418-3150
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53916]]
Fish and Fisheries Product Hazards and Control Guide 1996 Seafood Industry Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Submitting Requests Under 21 CFR 170.39, 1996 Food Packaging Industry Office of Premarket Approval, Food and Drug Administration
Threshold of Regulation for Substances Used in Food (HFS-200), 200 C St. SW., Washington, DC 20204, 202-418-
Articles 3100
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidelines for the Preparation of Petition 1996 Food Ingredient or Packaging Industry Do
Submissions
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline for Approval of Color Additives in Contact 1996 Color or Contact Lens Industry Do
Lenses Intended as Colors
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
FDA Recommendations for Submission of Chemical and February 1993 Color Additives Industry Do
Technological Data on Color Additives for Food,
Drugs or Cosmetics Use
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Points to Consider for the Use of Recycled Plastics December 1992 Food Packaging Industry Do
in Food Packaging: Chemistry Considerations
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Recommendations for Submission of Chemical and May 1993 Food Packaging Industry Do
Technological Data for Direct Food Additive and GRAS
Food Ingredient Petitions
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Recommendations for Chemistry Data for Indirect Food June 1995 Food Packaging Industry Do
Additive Petitions
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Enzyme Preparations: Chemistry Recommendations for January 1993 Food Enzyme Industry Do
Food Additive and GRAS Affirmation Petitions
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Estimating Exposure to Direct Food Additive and September 1995 Food and Food Ingredient Industry Do
Chemical Contaminants in the Diet
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Toxicological Principles for the Safety Assessment of 1982 Petitioners for Food or Color Additives National Technical Information Service (NTIS), 5285 Port
Direct Food Additives and Color Additives Used in Royal Rd., Springfield, VA 2216, (NT IS Order No. PR-83-
Food (also known as Redbook I) 170696
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Environmental Assessment Technical Handbook March 1987 Petitioners for Food or Color Additives Do (NTIS Order No. PB87175345-AS, A-01)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Color Additive Petitions Information and Guidance 1996 Petitioners for Color Additives Office of Premarket Approval, Food and Drug Administration
(HFS-200), 200 C St. SW., Washington, DC 20204, 202-418-
3100
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Toxological Testing of Food Additives 1983 Petitioners for Food or Color Additives Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
List of Products for Each Product Category October 8, 1992 Food Industry Office of Nutritional Products, Labeling, and Dietary
Supplements (HFS-800), Food and Drug Administration, 200 C
St. SW., Washington, DC 20204, 202-205-4561
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Label Declaration of Allergenic Substances in Foods; June 10, 1996 Food Industry Do
Notice to Manufacturers
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Labeling of Foods That Need Refrigeration February 24, 1997 Food Industry Do
by Consumers
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidelines Concerning Notification and Testing of 1985 Infant Formula Manufacturers Do
Infant Formula
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53917]]
Guidelines for the Evaluation of Safety and 1988 Infant Formula Manufacturers Do
Suitability of New Infant Formulas for Feeding
Preterm Infants
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Testing of Infant Formulas With Respect to 1988 Infant Formula Manufacturers Do
Nutritional Suitability for Term Infants
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidelines for the Evaluation of the Safety and 1990 Infant Formula Manufacturers Do
Suitability of Infant Formulas for Feeding Infants
With Allergic Diseases
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidelines for the Clinical Evaluation of New 1987 Infant Formula Manufacturers Do
Products Used in the Dietary Management of Infants,
Children and Pregnant Women With Metabolic Disorders
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for Arsenic (Trace Elements in January 1993 States Office of Seafood, Food and Drug Administration (HFS-400),
Seafood) 200 C St. SW., Washington, DC 20204, 202-418-3150,
Internet: FDA Home Page Http://vm.cfsan.fda.gov/list.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for Cadmium (Trace Elements in January 1993 States Do
Seafood)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for Chromium (Trace Elements in January 1993 States Do
Seafood)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for Lead (Trace Elements in August 1993 States Do
Seafood)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for Nickel (Trace Elements in January 1993 States Do
Seafood)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Consultation Procedures for Foods Derived October 1997 Regulated Industry Office of Premarket Approval (HFS-200), 200 C St. SW.,
From New Plant Varieties Washington, DC 20204, 202-418-3100, Internet: FDA Home Page
Http://vm.cfsan.fda.gov
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
FDA's Policy for Foods Developed by Biotechnology 1995 Food Industry Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Bovine Spongiform Encephalopathy (BSE) in Products 1997 Food Industry Office of Plant and Dairy Foods and Beverages (HFS-302),
for Human Use Center for Food Safety and Applied Nutrition, 200 C St.
SW., Washington, DC 20204, 202-205-9175, Internet: FDA Home
Page Http://www.fda.gov/opacom/morechoices/industry/guidance/gelguide.htm
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Interim Guidance on the Voluntary Labeling of Milk February 1994 Regulated Industry Office of Nutritional Products, Labeling, and Dietary
and Milk Products That Have Not Been Treated With Supplements (HFS-800), Food and Drug Administration, 200 C
Recombinant Bovine Somatropin St. SW., Washington, DC 20204, 202-205-4168
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Shellfish Sanitation Model Ordinance 1995 States Shellfish Program Implementation Branch, Division of
Cooperative Programs, Office of Field Programs (HFS-628),
200 C St. SW., Washington, DC 20204, 202-205-8137
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Minimize Microbial Hazards for Fresh Fruits 1998 Farmers and Food Packers Food Safety Initiative (HFS-32), Center for Food Safety and
and Vegetables (Available in English, Spanish, Applied Nutrition, 200 C St. SW., Washington, DC 20204, or
Portuguese, and French) [email protected]
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53918]]
Iron-Containing Supplements and Drugs: Label Warning 1997 Dietary Supplement Manufacturers: Small Office of Nutritional Products, Labeling, and Dietary
and Unit Dose Packaging; Small Entity Compliance Entities Supplements (HFS-450), Center for Food Safety and Applied
Guide Nutrition, 200 C St. SW., Washington, DC 20204
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Partial List of Enzyme Preparations That Are Used in 1998 FDA Regulated Industry Office of Premarket Approval (HFS-200), Center for Food
Foods Safety and Applied Nutrition, 200 C St. SW., Washington, DC
20204
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Partial List of Microorganisms and Microbial-Derived 1998 FDA Regulated Industry Do
Ingredients That Are Used in Food
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Fish and Fishery Products Hazards and Controls Guide, January 1998 FDA Regulated Industry Office of Seafood (HFS-400), Center for Food Safety and
2d Edition Applied Nutrition, 200 C St. SW., Washington, DC 20204
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
HACCP Regulations for Fish and Fishery Products: 1998 FDA Regulated Industry Do
Questions and Answers
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Notification of a Health Claim or Nutrient Content 1998 FDA Regulated Industry Office of Nutritional Products, Labeling, and Dietary
Claim Based on an Authoritative Statement of a Supplements (HFS-150), Center for Food Safety and Applied
Scientific Body Nutrition, 200 C St. SW., Washington, DC 20204
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
FDA Nutrition Labeling Manual, A Guide for Developing March 1998 FDA Regulated Industry Do
and Using Data Bases
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
HACCP Regulation for Fish and Fishery Products: January 1999 Seafood Processors Office of Seafood (HFS-400), Center for Food Safety and
Questions and Answers, Issue Three, Revised January Nutrition, 200 C St. SW., Washington, DC 20204, Ellen
1999 Nesheim, 202-418-3150
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Foods--Adulteration Involving Hard or Sharp Foreign February 1999 FDA Field Offices Office of Plant and Dairy Foods and Beverages (HFS-300),
Objects (CPG) Center for Food Safety and Applied Nutrition, 200 C St.
SW., Washington, DC 20204
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Food Additive Petition Expedited Review January 1999 Guidance for Industry and Center for Robert L. Martin (HFS-215), OPA/CFSAN/FDA, 200 C St. SW.,
Food Safety and Applied Nutrition Staff Washington, DC 20204, 202-418-3074, [email protected]
or http://vm.cfsan.fda.gov/6dms/opa-expe.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Use of Antibiotic Resistance Marker Genes in September 1998 Guidance for Industry Nega Beru (HFS-206), OPA/CFSAN/FDA, 200 C St. SW.,
Transgenic Plants Washington, DC 20204, 202-418-3097, [email protected]
or http://vm.cfsan.fda.gov//6dms/opa-armg.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance: Channels of Trade Policy for Commodities December 2000 Regulated Industry Office of Plant and Dairy Foods and Beverages, Center for
With Methyl Parathion Residues Food Safety and Applied Nutrition (HFS-300), FDA, 200 C St.
SW., Washington, DC 20204, http://vm.cfsan.fda.gov/`dms
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance: Fumonisin Levels in Human Foods and June 2000 Regulated Industry Do
Animal Feeds
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Statement of Identity, Nutrition Labeling, and January 1999 Small Business Entities Industry Activities Staff (HFS-565), Center for Food Safety
Ingredient Labeling of Dietary Supplements Small and Applied Nutrition, FDA, 200 C St. SW., Washington, DC
Entity Compliance Guide 20204, 202-205-5251
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Significant Scientific Agreement in the Review of December 1999 Regulated Industry Office of Nutritional Products, Labeling, and Dietary
Health Claims for Conventional Foods and Dietary Supplements, Center for Food Safety and Applied Nutrition,
Supplements (December 1999) FDA, 200 C St. SW., Washington, DC 20204, 202-205-4561
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53919]]
Antimicrobial Food Additives July 1999 Regulated Industry Office of Premarket Approval (HFS-200), Center for Food
Safety and Applied Nutrition, FDA, 200 C St. SW.,
Washington, DC 20204, 202-418-3100
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Preparation of Premarket Notifications for Food November 1999 Regulated Industry Do
Contact Substances: Chemistry Recommendations
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Preparation of Premarket Notifications for Food November 1999 Regulated Industry Do
Contact Substances: Toxicology Recommendations
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Small Businesses: Submission of Comments October 1999 Small Business Entities Division of Market Studies (HFS-726), Center for Food Safety
for CFSAN Rulemaking and Applied Nutrition, Food and Drug Administration,
Washington, DC 20204, 202-401-4590
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Warning and Notice Statement: Labeling of Juice September 1998 Regulated Industry Office of Nutritional Products, Labeling, and Dietary
Products Small Entity Compliance Guide Supplements, Center for Food Safety and Applied Nutrition,
FDA, 200 C St. SW., Washington, DC 20204, 202-205-4561
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Reducing Microbial Food Safety Hazards for Sprouted October 1999 Regulated Industry Office of Plant and Dairy Foods and Beverages, Center for
Seeds Food Safety and Applied Nutrition, FDA, 200 C St. SW.,
Washington, DC 20204, 202-205-4064
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Sampling and Microbial Testing of Spent Irrigation October 1999 Regulated Industry Do
Water During Sprout Production
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Seafood HACCP Transition Policy December 1999 Regulated Industry Office of Seafood (HFS-400), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-205-3150
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
FDA Recommendations for Sampling and Testing Yellow January 19, 2001 Regulated Industry Office of Plant and Dairy Foods and Beverages, Center for
Corn Shipments for Cry9C Protein Residues Food Safety and Applied Nutrition, FDA, 200 C St. SW.,
Washington, DC 20204, 202-205-4064
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance: Voluntary Labeling Indicating Whether January 2001 Regulated Industry Office of Premarket Approval (HFS-200), Center for Food
Foods Have or Have Not Been Developed Using Safety and Applied Nutrition, FDA, 200 C St. SW.,
Bioengineering Washington, DC 20204, 202-418-3100
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Bacteriological Analytical Manual 2001 Regulated Industry Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Importation of PMO Defined Dairy Products April 11, 2000 Dairy Industry Milk Safety Branch (HFS-626), Center for Food Safety and
Applied Nutrition, 200 C St. SW., Washington, DC 20204, 202-
205-9175
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance: Apple Juice, Apple Juice June 2000 Juice Industry Office of Plant and Dairy Foods and Beverages, Center for
Concentrates, and Apple Juice Products--Adulteration Food Safety and Applied Nutrition, FDA, 200 C St. SW.,
with Patulin Washington, DC 20204, 202-205-4064
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry on Refusal of Inspection November 2000 Seafood Industry Office of Seafood (HFS-400), Food and Drug Administration,
or Access to HACCP Records Pertaining to the Safe 200 C St. SW., Washington, DC 20204, 202-205-3150
and Sanitary Processing of Fish and Fishery Products
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53920]]
Withdrawals
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
How to Obtain A Hard Copy of the Document (Name and Address,
Name of Document Date of Issuance/Date Withdrawn Intended User or Regulatory Activity Phone, Fax, E-Mail or Internet)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
FDA Nutrition Labeling Manual: A Guide for Developing 1993/June 2001 Food Industry Office of Nutritional Products, Labeling, and Dietary
and Using Databases (Replaced by 1998 update with Supplements, Food and Drug Administration (HFS-800), 200 C
the same title.) St. SW., Washington, DC 20204, 202-205-4561
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Fabrication of Single Service Containers and Closures 1995/June 2001 States Milk Safety Branch, Center for Food Safety and Applied
for Milk and Milk Products (Incorporated into Nutrition, Food and Drug Administration, 200 C St. SW.,
Pasteurized Milk Ordinance as an appendix.) Washington, DC 20204, 202-205-9175
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
VI. Guidance Documents Issued by the Center for Veterinary Medicine (CVM)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Name of Document Date of Issuance Intended User or Regulatory Activity How to Obtain a Hard Copy of the Document
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Effectiveness of September 2000 Animal Drug Industry Internet via: http://www.fda.gov/cvm Communications Staff
Anthelmintics: Specific Recommendations for Equine (HFV-12), FDA/CVM, 7500 Standish Pl., Rockville, MD 20855,
(VICH GL15)--Draft 301-827-4582, FAX 301-594-1831
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Effectiveness of September 2000 Do Do
Anthelmintics: Specific Recommendations for Porcine
(VICH GL16)--Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Effectiveness of September 2000 Do Do
Anthelmintics: Specific Recommendations for Canine
(VICH GL19)--Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Effectiveness of December 2000 Do Do
Anthelmintics: Specific Recommendations for Feline
(VICH GL20)--Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Effectiveness of December 2000 Do Do
Anthelmintics: Specific Recommendations for Poultry
(VICH GL21)--Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Safety Studies for Veterinary December 2000 Do Do
Drug Residues in Human Food: Reproduction Studies
(VICH GL22)--Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Safety Studies for Veterinary December 2000 Do Do
Drug Residues in Human Food: Genotoxicity Studies
(VICH GL23)--Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Pharmacovigilance of December 2000 Do Do
Veterinary Medicinal Products: Management of Adverse
Event Reports (AERs)(VICH GL24)--Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Efficacy of Anthelmintics: March 2000 Do Do
General Recommendations (VICH GL7)--Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Efficacy of Anthelmintics: March 2000 Do Do
Specific Recommendations for Bovines (VICH GL12)--
Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Efficacy of Anthelmintics: March 2000 Do Do
Specific Recommendations for Ovines (VICH GL13)--
Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Efficacy of Anthelmintics: March 2000 Do Do
Specific Recommendations for Caprines (VICH GL14)--
Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53921]]
Guidance for Industry: Environmental Impact March 2000 Do Do
Assessments (EIAs) for Veterinary Medicinal Products
(VMPs)--Phase I (VICH GL6)--Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Stability Testing of New March 2000 Do Do
Biotechnological/Biological Veterinary Medicinal
Products (VICH GL17)--Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Good Clinical Practices (VICH May 2000 Do Do
GL9)--Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Impurities: Residual Solvents May 2000 Do Do
in New Veterinary Medicinal Products, Active
Substances and Excipients (VICH GL18)--Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: How to Use E-Mail to Submit a February 2000 Do Do
Notice of Final Disposition of Animals Not Intended
for Immediate Slaughter (NFDAs)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: How to Use E-Mail to Submit a February 2000 Do Do
Notice of Intent to Slaughter for Human Food
Purposes
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: How to Use E-Mail to Submit a February 2000 Do Do
Request for a Meeting or Teleconference to the
Office of New Animal Drug Evaluation
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
How to Use E-Mail to Submit Information to the Center February 2000 Do Do
for Veterinary Medicine--Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Dioxin in Anti-Caking Agents Used in Animal Feed and Revised April 2000 Do Do
Feed Ingredients
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Fumonisin Levels in Human June 2000 Do Do
Foods and Animal Feeds--Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
The Use of Published Literature in Support of New November 2000 Do Do
Animal Drug Approval
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Bioequivalence Guidance Revised October 2000 Do Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry #124: Voluntary Labeling January 2001 Do Do
Indicating Whether Foods Have or Have Not Been
Developed Using Bioengineering--Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry #126: BACPAC I: Intermediates February 2001 Do Do
in Drug Substance Synthesis Bulk Actives
Postapproval Changes: Chemistry, Manufacturing, and
Controls Documentation, February 2001
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry #120: Veterinary Feed Directive March 2001 Do Do
Regulation
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry #121: Expedited Review for New March 2001 Do Do
Animal Drug Applications for Human Pathogen
Reduction Claims
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53922]]
Guidance for Industry and Reviewers: How the Center March 2001 Do Do
for Veterinary Medicine Intends to Handle Deficient
Submissions Filed During the Investigation of a New
Animal Drug--Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
VII. Guidance Documents Issued by the Office of Policy (OP)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Name of Document Date of Issuance Intended User or Regulatory Activity How to Obtain a Hard Copy of the Document
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry; Exports and Imports June 12, 1998 Regulated Industry Internet via www.fda.gov/opacom/fedregister/frexport.html or
Under the FDA Export Reform and Enhancement Act of 63 FR 32219, June 12, 1998, or Office of Policy, 301-827-
1996 3360
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Direct Final Rule Guidance November 21, 1997 FDA Personnel Internet via www.fda.gov/opacom/morechoices/industry/guidance.htm or 62 FR 62467, November 21, 1997, or Office
of Policy, 301-827-3480
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
International Harmonization; Policy on Standards October 1995 FDA Personnel and Regulated Industry 60 FR 53078, October 11, 1995, or Office of Policy, 301-827-
3360
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Withdrawals
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Name of Document Date of Issuance Intended User or Regulatory Activity Date Withdrawn
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
FDA's Development, Issuance and Use of Guidance February 27, 1997 FDA Personnel and Regulated Industry September 19, 2000
Documents
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Small Entities Compliance Guide On: Regulations To February 1997 Regulated Industry March 31, 2000
Restrict the Sale and Distribution of Cigarettes and
Smokeless Tobacco in Order to Protect Children and
Adolescents (21 CFR Part 897)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Children and Tobacco--Frequently Asked Questions July 1997 Regulated Industry March 31, 2000
About the New Regulations (Draft)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Children and Tobacco--A Retailers Guide to the New October 1997 Regulated Industry March 31, 2000
Federal Regulations
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Children and Tobacco--A Guide to the New Federal October 1997 Regulated Industry March 31, 2000
Regulations
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
VIII. Guidance Documents Issued by the Office of Regulatory Affairs (ORA)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Name of Document Date of Issuance Intended User or Regulatory Activity How to Obtain a Hard Copy of the Document
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Policy Guide Manual--Compliance Policy August 2000 FDA Staff National Technical Information Service (NTIS) 5285 Port
Guidance for FDA Staff (Replaces Compliance Policy Royal Rd., Springfield, VA 22161 or Internet at:
Guide--January 1996) www.fda.gov/ora/cpgm/default.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Policy Guide, New Sec. 615.115 Extra-Label April 2001 Do Division of Compliance Policy (HFC-230), Office of
Use of Medicated Feeds for Minor Species Enforcement, Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301-827-0420 or via Internet at:
www.fda.gov/ora/compliance--;ref/rpm/rpmtc.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53923]]
Compliance Policy Guide, New Sec. 555.250 Statement April 2001 Do Do
of Policy for Labeling and Preventing Cross-Contact
of Common Food Allergens
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Policy Guide, Reformat Sec. 220.100 March 2001 Do Do
Interstate Shipment of Biological Products for Use
in Medical Emergencies
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Policy Guide, Reformat Sec. 270.100 Final March 2001 Do Do
Container Labels--Allergenic Extracts Containing
Glycerin; Reporting Changes
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Policy Guide, Draft Sec. 230.150, Blood December 2000 Do Do
Donor Incentives
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Policy Guide, Draft Distributor Medical August 28, 1997 FDA Staff Personnel and Regulated Do Internet at: www.fda.gov/ora/compliance--;ref/cpg--
Reporting Industry ;mdr3.txt
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Policy Guide Sec. 7150.09 Fraud, July 1991 FDA Staff and Regulated Industry Do Internet at: www.fda.gov/ora/compliance--;ref/aip--
Statements of Material Facts, Bribery, and Illegal ;page.html
Gratuities
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Medical Device Warning Letter Pilot March 8, 1999 FDA Staff and Regulated Industry Do Internet at: www.fda.gov/ohrms/Dockets/98fr/030899e.pdf
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Glossary of Computerized System and Software August 1995 Do National Technical Information Service (NTIS) 5285 Port
Development Terminology Royal Rd., Springfield, VA 22161 (NTIS Order No. PB96-
127352) or via Internet: www.fda.gov/ora/inspect--;ref/igs/
iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidelines for Entry Review of Radiation-Emitting March 12, 1999 FDA Staff Division of Import Operations and Policy (HFC-170), Office
Electronic Devices of Regional Operations, Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-1218
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Laboratory Procedures Manual June 1994 Do Division of Field Science (HFC-141), Food and Drug
Administration, 5600 Fishers Lane, rm. 12-41, Rockville, MD
20857, or Internet at: www.fda.gov/ora/science--;ref/lpm/
lpmtc.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Laboratory Procedures Manual Chapter X, New: Method May 1999 Do Do
Validation Samples
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Memorandum: ORA Investigational Strategy on Gamma- May 15, 2000 Do Division of Emergency and Investigational Operations (HFC-
Butyrolactone (GBL) and Related Products 130), Office of Regional Operations, Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, Not
Available on the Internet
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Investigations Operations Manual January 2001 Do National Technical Information Service (NTIS) 5285 Port
Royal Rd., Springfield, VA 22161 (NTIS Order No. PB2001-
913399 and Internet at www.fda.gov/ora/inspect--;ref/iom/
default.htm)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Medical Devices: Draft Guidance entitled ``Guidance Released for Comment June 8, 1999 FDA Staff Division of Compliance Policy (HFC-230), Office of
for FDA Staff on Civil Money Penalty Policy'' Enforcement, Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301-827-0420, or Internet at:
http://www.fda.gov/ohrms/dockets/98fr/060899e.pdf
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53924]]
Regulatory Procedures Manual Update/New Subchapter 5 April 19, 2001 Do Do Internet at: www.fda.gov/ora/compliance--;ref/rpm/
Civil Money Penalty Reduction Policy for Small rpmtc.html
Entities
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Regulatory Procedures Manual New RPM Subchapter: January 2001 Do Do Internet at: www.fda.gov/ora/compliance--;ref/rpm/
Communication Concerning Assessment of Civil rpmtc.html
Monetary Penalties by U.S. Customs Service in Cases
Involving Imported Food
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Regulatory Procedures Manual: Update, New Subchapter March 1998 Do Division of Compliance Policy (HFC-230), Office of
Application Integrity Policy Enforcement, Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301-827-0420 or via Internet at:
www.fda.gov/ora/compliance--;ref/rpm/rpmtc.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Regulatory Procedures Manual: Update/Revision April 1998 Do Do
Subchapter/Priority Enforcement Strategy for Problem
Importers
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Regulatory Procedures Manual: Update/Revision April 1998 Do Do
Subchapter/Import Procedures
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Regulatory Procedures Manual: Update/Revision April 1998 FDA Staff Do
Subchapter/Notice of Sampling
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Regulatory Procedures Manual: Update New Subchapter/ May 1998 Do Do
Granting and Denying Transportation and Exportation
(T&E) Entries
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Regulatory Procedures Manual: Update/Revision June 1998 Do Do Internet at: www.fda.gov/ora/compliance--;ref/rpm--;new2/
Subchapter/Seizure ch6.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Regulatory Procedures Manual: Update/Revision June 1998 Do Do Internet at: www.fda.gov/ora/compliance--;ref/new2/
Subchapter/Supervisory Charges ch9chgs.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Regulatory Procedures Manual: New Subchapter: Civil July 1998 Do Do Internet at: www.fda.gov/ora/compliance--;ref/
Penalties--Electronic Product Radiation Control ch6civpen.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Regulatory Procedures Manual: Update/Revision, March 21, 2000 Do Do Internet at: www.fda.gov/ora/compliance--;ref/rpm--;new2/
Chapter 4, Subchapter/Warning Letters ch4.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Regulatory Procedures Manual New Chapter 9, January 2001 Do Do Internet at: www.fda.gov/ora/compliance--;ref/rpm--;new2/
Communication Concerning Assessment of Civil ch9civmonpen.html
Monetary Penalties by U.S. Customs in Cases
Involving Imported Food
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Regulatory Procedures Manual New Chapter 9, Secured January 2001 Do Do Internet at: www.fda.gov/ora/compliance--;ref/rpm--;new2/
Storage ch9securedstorage.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Bulk Pharmaceutical Chemicals May 1994 Do National Technical Information Service (NTIS), 5285 Port
Royal Rd., Springfield, VA 22161, (NTIS Order No. PB96-
127154) or via Internet at: www.fda.gov/ora/inspect)--;ref/
igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Pharmaceutical Quality July 1993 Do Do (NTIS Order No. PB96-127279) or via Internet at:
Control Laboratories www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53925]]
Guide to Inspections of Microbiological July 1993 Do Do (NTIS Order No. PB96-127287) or via Internet at:
Pharmaceutical Quality Control Laboratories www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Validation of Cleaning July 1993 Do Do (NTIS Order No. PB96-127246) or via Internet at:
Processes www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Lyophilization of Parenterals July 1993 Do Do (NTIS Order No. PB96-127253) or via Internet at:
www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of High Purity Water Systems July 1993 Do Do (NTIS Order No. PB96-127261) or via Internet at:
www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Dosage Form Drug October 1993 Do Do (NTIS Order No. PB96-127212) or via Internet at:
Manufacturers--CGMPs www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Oral Solid Dosage Forms Pre/ January 1994 Do Do (NTIS Order No. PB96-127345) or via Internet at:
Post Approval Issues for Development and Vaccination www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Topical Drug Products July 1994 Do Do (NTIS Order No. PB96-127394) or via Internet at:
www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Sterile Drug Substance July 1994 Do Do (NTIS Order No. PB96-127295) or via Internet at:
Manufacturers www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Oral Solutions and August 1994 Do Do (NTIS Order No. PB96-127147) or via Internet at:
Suspensions www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Nutritional Labeling and February 1995 Do Do (NTIS Order No. PB96-127378) or via Internet at:
Education Act (NLEA) Requirements www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Interstate Carriers and April 1995 Do Do (NTIS Order No. PB96-127386) or via Internet at:
Support Facilities www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Dairy Product Manufacturers April 1995 Do Do (NTIS Order No. PB96-127329) or via Internet at:
www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Miscellaneous Foods Vol. 1 May 1995 Do Do (NTIS Order No. PB97-127220) or via Internet at:
www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Miscellaneous Foods Vol. 11 September 1996 Do Do (NTIS Order No. PB97-196133) or via Internet at:
www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Low Acid Canned Foods November 1996 Do Do (NTIS Order No. PB97-196141) or via Internet at:
Manufacturers, Part 1--Administrative Procedures/ www.fda.gov/ora/inspect--;ref/igs/iglist.html
Scheduled Processes
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Cosmetic Product February 1995 Do Do (NTIS Order No. PB96-127238) or via Internet at:
Manufacturers www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Low Acid Canned Foods April 1997 Do Do (NTIS Order No. PB97-196158) or via Internet at:
Manufacturers, Part 2--Processes/ Procedures www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53926]]
Guide to Inspections of Low Acid Canned Foods July 2001 FDA Staff Do (NTIS Order No. PB00-133795)
Manufacturers, Part 3--Container Closurers
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Blood Banks September 1994 Do Do (NTIS Order No. PB96-127303) or via Internet at:
www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Source Plasma Establishments December 1994 Do Do (NTIS Order No. PB96-127360) or via Internet at:
www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Infectious Disease Marker June 1996 Do Do (NTIS Order No. PB96-199476) or via Internet at:
Testing Facilities www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Biotechnology Inspections Guide November 1991 Do Do (NTIS Order No. PB96-127402) or via Internet at:
www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Computerized Systems in Drug February 1983 Do Do (NTIS Order No. PB96-127337) or via Internet at:
Processing www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Foreign Medical Device September 1995 Do Do (NTIS Order No. PB96-127311) or via Internet at:
Manufacturers www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Foreign Pharmaceutical May 1996 Do Do (NTIS Order No. PB96-199468) or via Internet at:
Manufacturers www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Mammography Quality Standards Act (MQSA) Auditors January 1998 Do Do (NTIS Order No. PB98-127178) or via Internet at:
Guide www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Electromagnetic Compatibility December 1997 Do Do (NTIS Order No. PB98-127152) or via Internet at:
Aspects of Medical Device Quality Systems www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Acidified Food Manufacturers May 1998 Do http://www.fda.gov/ora/inspect--;ref/igs/acidfgde.htm
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspection of Aseptic Processing and February 2001 Do Division of Emergency and Investigational Operations (HFC-
Packaging for the Food Industry 130), Office of Regional Operations, Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-
443-1240
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Grain Product Manufacturers March 1998 Do (NTIS Order No. PB-98-137128) or via Internet at:
www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Bioresearch Monitoring Inspections of In February 1998 Do Do Internet at: www.fda.gov/ora/inspect--;ref/igs/
Vitro Devices iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Viral Clearance Processes for March 1998 Do Do Internet at: www.fda.gov/ora/inspect--;ref/igs/
Plasma Derivatives iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Trace Back of Fresh Fruits and Vegetables April 2001 Do Do Internet at: www.fda.gov/ora/inspect--;ref/igs/
Implicated in Epidemiological Investigations iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Computerized Systems in the August 1998 Do Do Internet at: www.fda.gov/ora/inspect--;ref/igf/
Food Processing Industry foodcomp.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to International Inspections and Travel, July 1999 Do Do Revision not available on Internet
Revision (Formerly, FDA/ORA International Inspection
Manual and Travel Guide)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53927]]
Guide to Inspections of Quality Systems August 1999 Do Do Internet at: www.fda.gov/ora/inspect--;ref/igs/qsit/
QSITGUIDE.PDF
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspection of Firms Producing Food Products April 2001 Do Do Internet at: http://www.fda.gov/ora/inspect--;ref/igs/
Susceptible to Contamination with Allergenic iglist.html
Ingredients
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Computerized Systems Used in Clinical Trials April 1999 Do Do Internet at: www.fda.gov/ora/compliance--;ref/bimo/
ffinalact.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Program 7348.001: Bioresearch Monitoring, October 1, 1999 D0 Do Internet at: www.fda.gov/ora/compliance--;ref/Bimo/7348--
Human Drugs, In Vivo Bioequivalence ;001/default.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Good Laboratory Practice Program (Nonclinical October 1, 1991 Do Division of Compliance Policy (HFC-230), Office of
Laboratories) 7348.808A; EPA Data Audit Inspections Enforcement, Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301-827-0420
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline for the Monitoring of Clinical January 1988 FDA Regulated Industry Division of Compliance Policy (HFC-230), Office of
Investigators Enforcement, Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301-827-0420
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Small Business Guide to FDA (FDA 96-1092) January 1, 1996 Do Federal-State Relations (HFC-150), Office of Regulatory
Affairs, Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-2905 Internet at: www.fda.gov/ora/indust--;assit/default.htm
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Program 7348.808 Bioresearch Monitoring: Revised August 17, 1998 FDA Staff Do Internet at: www.fda.gov/ora/compliance--;ref/bimo/
Good Laboratory Practices (Nonclinical) default.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Program 7348.809 Bioresearch Monitoring: August 18, 1994 Do Do
Institutional Review Board
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Program 7348.810: Sponsors, Contract Revised October 30, 1998 Do Do
Research Organizations and Monitors
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Good Laboratory Practice Regulations Management August 1979 Do Do Internet at: www.fda.gov/ora/compliance--;ref/bimo/
Briefings default.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Draft: Guidance for Institutional Review Boards, March 31, 2000 FDA Regulated Industry Do
Clinical Investigators, and Sponsors: Exception from
Informed Consent Requirements for Emergency Research
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Dated: October 9, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-26650 Filed 10-23-01; 8:45 am]
BILLING CODE 4160-01-S