[Federal Register: July 30, 1998 (Volume 63, Number 146)] [Notices] [Page 40720-40721] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr30jy98-71] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 98D-0449] ``Draft Compliance Program Guidance Manual: Inspection of Medical Device Manufacturers;'' Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Draft Compliance Program Guidance Manual: Inspection of Medical Device Manufacturers.'' This draft guidance provides guidance to the FDA field staff for the enforcement of the requirements of the quality system regulation, and it includes guidance on the amendments to the quality system regulation, which became effective June 1, 1997. This draft guidance is intended to represent the agency's current thinking on inspection of medical device manufacturers, and it is not final nor is it in effect at this time. DATES: Written comments may be provided at any time, however, comments should be submitted by October 28, 1998. ADDRESSES: Submit written requests for single copies on a 3.5'' diskette of the guidance document entitled ``Draft Compliance Program Guidance Manual: Inspection of Medical Device Manufacturers'' 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 one self-addressed adhesive label 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 the guidance. Submit written comments on the document to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Wes W. Morgenstern, Center for Devices and Radiological Health (HFZ-305), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-4699. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft document entitled ``Draft Compliance Program Guidance Manual: Inspection of Medical Device [[Page 40721]] Manufacturers'' (CP 7382.830). This draft document provides guidance to the FDA field staff for the enforcement of the quality system regulation (part 820 (21 CFR part 820)). This draft is a revision to the document first made available in May 1995, in accordance with the amendments to part 820, effective June 1, 1997. This guidance document represents the agency's current thinking on inspection of medical device manufacturers. 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 document is issued as a Level 1 guidance consistent with GGP's. II. Electronic Access In order to receive the ``Draft Compliance Program Guidance Manual: Inspection of Medical Device Manufacturers'' (CP 7382.830) 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 (487) 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 Compliance Program Guidance Manual: Inspection of Medical Device Manufacturers'' (CP 7382.830), 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''. The ``Draft Compliance Program Guidance Manual: Inspection of Medical Device Manufacturers'' (CP 7382.830) will be available at ``http://www.fda.gov/cdrh/ochome.html''. 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. II. Comments This draft document is being distributed for comment purposes only and is not intended for implementation at this time. Interested persons may submit to Dockets Management Branch (address above) written comments regarding this draft guidance document. Written comments may be submitted at any time, however, comments should be submitted by October 28, 1998, to ensure adequate consideration in preparation of the final document. Two copies of any comments are to be submitted, except individuals may submit one copy. Comments should be identified with the docket number found in brackets in the heading of this document. A copy of the document and received comments are available for examination in the the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday. Dated: July 17, 1998. D.B. Burlington, Director, Center for Devices and Radiological Health. [FR Doc. 98-20305 Filed 7-29-98; 8:45 am] BILLING CODE 4160-01-F