[Federal Register Volume 63, Number 214 (Thursday, November 5, 1998)]
[Pages 59793-59794]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-29567]



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

Guidance for Industry on General/Specific Intended Use; 

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


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.


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 

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]