Reports and guidance documents; availability, etc.: Medical devices; general/specific intended use; industry guidance,

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Federal Register: May 22, 1998 (Volume 63, Number 99)NoticesPage 28392From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr22my98-105

[Page 28392]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Docket No. 98D-0298Guidance for Industry on General/Specific Intended Use; Draft; Availability

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SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Guidance for Industry on General/Specific Intended Use.'' This draft guidance is not final or in effect at this time. The purpose of this draft guidance is to help medical device manufacturers understand the principles used by FDA to determine whether the addition of a specific indication for use to a medical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 The draft guidance is intended to help manufacturers answer the following questions: Under what circumstances is a device with a new, specific indication for use likely to be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DATES: Written comments concerning this draft guidance must be submitted by June 22, 1998. ADDRESSES: Submit written requests for single copies on a 3.5'' diskette of the draft guidance entitled ``Guidance for Industry on General/Specific Intended Use'' to the Division of Small Manufacturers Assistance (HFZ-220), Center for Devices and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 Submit written comments concerning this draft guidance to the Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.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 See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance.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.

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. 98-13798Filed5-21-98; 8:45 amBILLING CODE 4160-01-F

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