[Federal Register Volume 63, Number 146 (Thursday, July 30, 1998)]
[Notices]
[Pages 40720-40721]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-20305]


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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.

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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draft guidance provides guidance to the FDA field staff for the 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 This draft guidance is 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 
(<SUP><greek-i></SUP>). 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 ``<a href="http://
www.fda.gov/cdrh">http://
www.fda.gov/cdrh</a>''. 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