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[Federal Register: February 25, 1998 (Volume 63, Number 37)] [Notices] [Page 9571-9572] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr25fe98-99] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. 98D-0106, 98D-0107, 98D-0108] Medical Devices; Postmarket Surveillance; Guidance Documents; Availability 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. SUPPLEMENTARY INFORMATION: 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/ modact. 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. 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] BILLING CODE 4160-01-F
Updated 2/25/1998
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