[Federal Register Volume 63, Number 214 (Thursday, November 5, 1998)]
[Notices]
[Pages 59793-59794]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-29567]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D-0298]
Guidance for Industry on General/Specific Intended Use;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``Guidance for Industry on
General/Specific Intended Use.'' FDA developed this guidance to satisfy
a new section of the Federal Food, Drug, and Cosmetic Act (the act),
which was added by the Food and Drug Administration Modernization Act
of 1997 (FDAMA). This new section directs the agency to issue guidance
explaining the general principles used by FDA in determining when a
specific use may be added to a legally marketed device using premarket
notification (510(k)) procedures and when a specific use triggers the
need for a premarket approval (PMA) application.
DATES: Written comments concerning this guidance may be submitted at
any time.
ADDRESSES: Submit written requests for single copies on a 3.5''
diskette of the guidance document to the Division of Small
Manufacturers Assistance (HFZ-220), Center for Devices and
Radiological, Food and Drug Administration, 1350 Piccard Dr.,
Rockville, MD 20850. Send two self-addressed adhesive labels to assist
that office in processing your electronic or written request, or fax
your request to 301-443-8818. Submit written comments on ``Guidance for
Industry on General/Specific Intended Use'' to the contact person. See
the SUPPLEMENTARY INFORMATION section for information on electronic
access to the guidance entitled ``Guidance for Industry on General/
Specific Intended Use.''
FOR FURTHER INFORMATION CONTACT: Daniel G. Schultz, Center for Devices
and Radiological Health (HFZ-470), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-5072.
SUPPLEMENTARY INFORMATION:
I. Background
Congress indicated that FDA should provide additional guidance on
the approach that the agency takes when evaluating whether a new use,
which appears to fall within the scope of the intended use of a legally
marketed predicate device, is a new intended use that would require a
PMA. This guidance is issued in accordance with the new section
513(i)(1)(F) of the act (21 U.S.C. 360c(i)(1)(f)), which was added by
section 206 of FDAMA. The purpose of this document is to help medical
device manufacturers understand the principles used by FDA to determine
whether the addition of a specific indication for use to a medical
device cleared for marketing with a general indication for use could
trigger the need for a PMA application. The guidance is intended to
help manufacturers answer the following questions: Under what
circumstances is the device with a new, specific indication for use
likely to be found to be substantially equivalent to a device legally
marketed for a general indications for use? Conversely, when does a
specific indication for use become a new intended use that requires
submission of a PMA to establish the safety and effectiveness of the
device? FDA announced the
[[Page 59794]]
availability of a draft guidance pertaining to General/Specific
Intended use in the Federal Register of May 22, 1998 (63 FR 28392). The
agency received two comments on the draft guidance. FDA has reviewed
the comments and has made some revisions to the guidance in response to
the comments.
II. Significance of Guidance
This guidance document represents the agency's current thinking on
General/Specific Intended Use. It does not create or confer any rights
for or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
applicable statute, regulations, or both.
The agency has adopted Good Guidance Practices (GGP's), which set
forth the agency's policies and procedures for the development,
issuance, and use of guidance documents (62 FR 8961, February 27,
1997). This guidance document is issued as a Level 1 guidance
consistent with GGP's.
III. Electronic Access
In order to receive ``Guidance for Industry on General/Specific
Intended Use'' via your fax machine, call the CDRH Facts-On-Demand
(FOD) system at 800-899-0381 or 301-827-0111 from a touch-tone
telephone. At the first voice prompt press 1 to access DSMA Facts, at
second voice prompt press 2, and then enter the document number 499
followed by the pound sign (#). Then follow the remaining voice prompts
to complete your request.
Persons interested in obtaining a copy of the guidance may also do
so using the World Wide Web (WWW). CDRH maintains an entry on the WWW
for easy access to information including text, graphics, and files that
may be downloaded to a personal computer with access to the WWW.
Updated on a regular basis, the CDRH home page includes ``Guidance for
Industry on General/Specific Intended Use,'' device safety alerts,
Federal Register reprints, information on premarket submissions
(including lists of approved applications and manufacturers'
addresses), small manufacturers' assistance, information on video
conferencing and electronic submissions, mammography matters, and other
device-oriented information. The CDRH home page may be accessed at
``http://www.fda.gov/cdrh''.
IV. Comments
Interested persons may, at any time, submit written comments
regarding this final guidance to the contact person. Such comments will
be considered when determining whether to amend the current guidance.
Dated: October 28, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-29567 Filed 11-4-98; 8:45 am]
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