[Federal Register Volume 63, Number 99 (Friday, May 22, 1998)]
[Notices]
[Page 28392]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-13798]
[[Page 28392]]
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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; Draft;
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availability of the draft guidance entitled ``Guidance for Industry on
General/Specific Intended Use.'' This draft guidance is not final or in
effect at this time. The purpose of this draft guidance is to help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 premarket approval application (PMA). The
draft guidance is intended to help manufacturers answer the following
questions: Under what circumstances is a device with a new, specific
indication for use likely to be found to be substantially equivalent to
a device legally marketed for a general indication 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?
DATES: Written comments concerning this draft guidance must be
submitted by June 22, 1998.
ADDRESSES: Submit written requests for single copies on a 3.5''
diskette of the draft guidance entitled ``Guidance for Industry on
General/Specific Intended Use'' to the Division of Small Manufacturers
Assistance (HFZ-220), Center for Devices and Radiological Health, Food
and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send
two self-addressed adhesive labels to assist that office in processing
your request, or fax your request to 301-443-8818. Submit written
comments concerning this draft guidance to the Dockets Management
Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm.
1-23, Rockville, MD 20857. Comments should be identified with the
docket number found in brackets in the heading of this document. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
draft guidance.
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
indication for 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 new section 513(i)(1)(F) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360c(i)(1)(F)), which was added by section 206 of the
Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-
115).
II. Significance of Guidance
This draft guidance 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 draft guidance is issued as a Level 1 guidance consistent
with GGP's.
III. Electronic Access
In order to receive copies of the draft guidance entitled
``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 the 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 draft 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
Web. Updated on a regular basis, the CDRH home page includes the draft
guidance entitled ``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.
A text-only version of the CDRH Web site is also available from a
computer or VT-100 compatible terminal by dialing 800-222-0185
(terminal settings are 8/1/N). Once the modem answers, press Enter
several times and then select menu choice 1: FDA BULLETIN BOARD
SERVICE. From there follow instructions for logging in, and at the BBS
TOPICS PAGE, arrow down to the FDA home page (do not select the first
CDRH entry). Then select Medical Devices and Radiological Health. From
there select CENTER FOR DEVICES AND RADIOLOGICAL HEALTH for general
information, or arrow down for specific topics.
IV. Comments
Interested persons may, on or before June 22, 1998, submit to the
Dockets Management Branch (address above) written comments regarding
this draft guidance. Two copies of any comments are to be submitted,
except that individuals may submit one copy. Comments are to be
identified with the docket number found in brackets in the heading of
this document. The guidance document and received comments may be seen
in the office above between 9 a.m. and 4 p.m., Monday through Friday.
Dated: May 12, 1998.
D.B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 98-13798 Filed 5-21-98; 8:45 am]
BILLING CODE 4160-01-F
