[Federal Register Volume 63, Number 37 (Wednesday, February 25, 1998)]
[Pages 9571-9572]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-4844]



Food and Drug Administration
[Docket Nos. 98D-0106, 98D-0107, 98D-0108]

Medical Devices; Postmarket Surveillance; Guidance Documents; 

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of three guidance documents on postmarket surveillance of 
medical devices. These guidance documents are being issued in order to 
facilitate the implementation of the postmarket surveillance provisions 
of the Federal Food, Drug, and Cosmetic Act (the act) as amended by the 
Food and Drug Administration Modernization Act of 1997. FDA will issue 
further guidance in the near future.

DATES: Submit written comments concerning these guidance documents by 
May 26, 1998.
ADDRESSES: Submit written to the Dockets Management Branch (HFA-305), 
Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, 
MD 20857. Submit written requests for single copies of these guidance 
documents on a 3.5'' diskette to the Division of Small Manufacturers 
Assistance, Center for Devices and Radiological Health (HFZ-220), 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. See the 
SUPPLEMENTARY INFORMATION section for information on electronic access 
to these guidance documents.
FOR FURTHER INFORMATION CONTACT: Anita Rayner, Center for Devices and 
Radiological Health (HFZ-543), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 301-594-0639.


I. Background

    The Safe Medical Devices Act of 1990 amended the act, among other 
things, to add section 522 (21 U.S.C. 360(l)) to require postmarket 
surveillance for certain medical devices. Section 522 was further 
amended by the Food and Drug Administration Modernization Act of 1997 
(FDAMA) (Pub. L. 105-115). As amended, section 522 of the act revises 
the criteria for determining which devices are subject to postmarket 
surveillance and revises the procedures for implementing postmarket 
surveillance. The revised provisions of section 522 become effective on 
February 19, 1998.
    FDA is making the following guidance documents available at this 
time in order to facilitate the initial implementation of the revised 
postmarket surveillance provisions:
    1. Guidance on Procedures to Determine Application of Postmarket 
Surveillance Strategies (Docket No. 98D-0106 (FOD # 316));
    2. Guidance on Procedures for Review of Postmarket Surveillance 
Submissions (Docket No. 98D-0107 (FOD # 317)); and

[[Page 9572]]

    3. SMDA to FDAMA: Guidance on FDAs Transition Plan for Existing 
Postmarket Surveillance Protocols (Docket No. 98D-0108 (FOD # 318)).
    These guidance documents represent the agency's current thinking on 
postmarket surveillance. They do not create or confer any rights for or 
on any person and do not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
applicable statute, regulations, or both.

II. Electronic Access

    In order to receive these guidance documents 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 found next to the title of the document listed above 
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). The Center for Devices and 
Radiological Health (CDRH) maintains an entry on the WWW for easy 
access to information including text, graphics, and files that may be 
downloaded to a PC with access to the Web. Updated on a regular basis, 
the CDRH Home Page includes information on the FDA Modernization Act, 
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. Information on the FDA 
Modernization Act is available at http://www.fda.gov/cdrh/modern/
    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.

III. Comments

    Interested persons may, by or before May 26, 1998, submit to the 
Dockets Management Branch written comments regarding these guidance 
documents. Two copies of any comments are to be submitted, except that 
individuals may submit one copy. Comments will be considered in 
determining whether to revise or revoke the guidance documents.

    Dated: February 19, 1998.
D. B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 98-4844 Filed 2-20-98; 3:59 pm]