[Federal Register Volume 63, Number 99 (Friday, May 22, 1998)]
[Page 28392]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-13798]

[[Page 28392]]



Food and Drug Administration
[Docket No. 98D-0298]

Guidance for Industry on General/Specific Intended Use; Draft; 

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


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availability of the draft guidance entitled ``Guidance for Industry on 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 This draft guidance is not final or in 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 The purpose of this draft guidance is to help 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draft guidance is intended to help manufacturers answer the following 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DATES: Written comments concerning this draft guidance must be 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diskette of the draft guidance entitled ``Guidance for Industry on 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comments concerning this draft guidance to the Dockets Management 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draft guidance.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.


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-

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 
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]