[Federal Register Volume 64, Number 79 (Monday, April 26, 1999)]
[Notices]
[Pages 20312-20313]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-10290]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99N-0924]
Food and Drug Administration Modernization Act of 1997; List of
Documents Issued by the Food and Drug Administration That Apply to
Medical Devices Regulated by the Center for Biologics Evaluation and
Research
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is publishing a list
of documents issued in response to the Food and Drug Administration
Modernization Act of 1997 (FDAMA), and clarifying their applicability
to medical devices regulated by the Center for Biologics Evaluation and
Research (CBER). This notice is intended to inform the public of the
availability of these documents, clarify their scope of applicability,
and to provide instructions on ways to access them.
ADDRESSES: Submit written requests for single copies of the document
to the Division of Small Manufacturers Assistance (HFZ-220), Center for
Devices and Radiological Health (CDRH), Food and Drug Administration,
1350 Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive
labels to assist that office in processing your requests, or fax your
request to 301-443-8818. The document may also be obtained by fax by
calling the CDRH Facts-on-Demand at 1-800-899-0381 or 301-827-0111. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
documents.
FOR FURTHER INFORMATION CONTACT: Astrid L. Szeto, Center for Biologics
Evaluation and Research (HFM-17), Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852-1448, 301-827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
On November 21, 1997, the President signed into law FDAMA (Pub. L.
105-115). CBER is working closely with CDRH in the implementation of
the provisions of FDAMA applicable to medical devices. However, early
in the implementation of FDAMA, several documents were issued with
explicit applicability to CDRH regulated devices, but for which
applicability to CBER regulated devices was unclear. To clarify that
these documents are also applicable to medical devices regulated by
CBER, FDA is providing the public with this list of documents in
section II of this document, acknowledging that the documents are
utilized by CBER in its review of medical devices, and providing
instructions on ways to access them. The documents in this list are
applicable to any device regulated under the medical device amendments
of the Federal Food, Drug, and Cosmetic Act (e.g., 510(k) exempt,
510(k), premarket approval). CBER has endorsed these documents and
intends to follow the procedures as appropriate.
This list is organized by: (1) Guidances, (2) notices, and (3)
rulemakings. Guidance documents that do not have a date and cite of
publication in the Federal Register were issued directly on the
Internet. Although certain documents on the list may reference specific
organizational elements and contact points in CDRH, this should not be
interpreted to mean that those are also the contact points for CBER.
The general contact point in CBER for medical device issues will be the
Associate Director for Regulatory Affairs in the Office of Blood
Research and Review, CBER.
II. Document References
--------------------------------------------------------------------------------------------------------------------------------------------------------
Date of Publication in the
Name of Document Date of Issuance1 Federal Register Federal Register cite
--------------------------------------------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidances
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on IDE Policies and Procedures2 (Level 2) January 20, 1998 N/A N/A
FDA Modernization Act of 1997: Guidance for the Device Industry on February 6, 1998 February 6, 1998 63 FR 6193
Implementation of Highest Priority Provisions
Determination of Intended Use for 510(k) Devices--Guidance for January 30, 1998 February 25, 1998 63 FR 9570
Industry and CDRH Staff
Guidance on the Recognition and Use of Consensus Standards February 20, 1998 February 25, 1998 63 FR 9561
Early Collaboration Meetings Under the FDA Modernization Act February 19, 1998 February 25, 1998 63 FR 9570
(FDAMA), Guidance for Industry and CDRH Staff
Guidance on PMA Interactive Procedures for Day-100 Meetings and February 19, 1998 February 25, 1998 63 FR 9570
Subsequent Deficiencies--For Use by CDRH and Industry
30-Day Notices and 135-Day PMA Supplements for Manufacturing Method February 19, 1998 February 25, 1998 63 FR 9570
or Process Changes, Guidance for Industry and CDRH
New Section 513(f)(2)--Evaluation of Automatic Class III February 19, 1998 February 25, 1998 63 FR 9570
Designation, Guidance for Industry and CDRH Staff
Procedures for Class II Device Exemptions from Premarket February 19, 1998 February 25, 1998 63 FR 9570
Notification, Guidance for Industry and CDRH Staff
Guidance On Procedures to Determine Application of Postmarket February 19, 1998 February 25, 1998 63 FR 9571
Surveillance Strategies
Guidance on Procedures for Review of Postmarket Surveillance February 19, 1998 February 25, 1998 63 FR 9571
Submissions
Guidance on Medical Device Tracking February 19, 1998 March 4, 1998 63 FR 10640
PMA/510(k) Expedited Review--Guidance for Industry and CDRH Staff March 20, 1998 March 31, 1998 63 FR 15427
[[Page 20313]]
Guidance to Industry Supplements to Approved Applications for Class May 20, 1998 May 21, 1998 63 FR 27988
III Medical Devices: Use of Published Literature, Use of Previously
Submitted Materials, and Priority Review
List of Devices for Third Party Review Under the FDA Modernization February 8, 1999 (list N/A N/A
Act of 19972 updated periodically)
List of Accredited Persons For 510(k) Review under the FDA October 2, 1998 ( list N/A N/A
Modernization Act of 19972 updated periodically)
Guidance for Staff, Industry, and Third Parties: Implementation of October 30, 1998 November 2, 1998 63 FR 58746
Third Party Programs Under the FDA Modernization Act of 1997
Guidance on Criteria and Approaches for Postmarket Surveillance November 2, 1998 November 3, 1998 63 FR 59315
Guidance for Industry: General/Specific Intended Use November 4, 1998 November 5, 1998 63 FR 59793
Guidance on Frequently Asked Questions on the Recognition and Use of December 21, 1998 N/A N/A
Consensus Standards2 (Level 2)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notices
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medical Devices; Exemptions From Premarket Notification; Class II January 21, 1998 63 FR 3142
Devices
Medical Devices; Exemptions From Premarket Notification and Reserved February 2, 1998 63 FR 5387
Devices; Class I
Medical Devices; Device Tracking; New Orders to Manufacturers March 4, 1998 63 FR 10638
Prompt Review of Supplemental Applications for Approved Devices May 21, 1998 63 FR 27987
Modifications to the List of Recognized Standards; Availability; October 16, 1998 63 FR 55617
Withdrawal of Draft Guidance ``Use of IEC 60601 Standards; Medical
Electrical Equipment''
--------------------------------------------------------------------------------------------------------------------------------------------------------
Rulemakings
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medical Devices; Reports of Corrections and Removals; Direct Final August 7, 1998 63 FR 42229
Rule
Medical Devices; Reports of Corrections and Removals; Companion to August 7, 1998 63 FR 42300
Direct Final Rule; Proposed Rule
Medical Devices; Exemptions from Premarket Notification ; Class II November 3, 1998 63 FR 59222
Devices
Medical Devices; Exemption from Premarket Notification and Reserved November 12, 1998 63 FR 63222
Devices; Class I
Medical Devices; Investigational Device Exemptions; Final Rule November 23, 1998 63 FR 64617
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The ``Date of Issuance'' is the date that the guidance was announced on the Internet.
\2\ Not applicable (N/A)--this document was not announced in the Federal Register. It was issued directly on the Internet.
III. Electronic Access
Persons with access to the Internet may obtain the documents using
the World Wide Web (WWW). For WWW access, connect to CBER at ``http://
www.fda.gov/cber/guidelines.htm'' for the guidance documents only.
Connect to CDRH at ``http://www.fda.gov/cdrh'' for all of the documents
listed.
Dated: April 19, 1999.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 99-10290 Filed 4-23-99; 8:45 am]
BILLING CODE 4160-01-F