[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draft guidance provides guidance to the FDA field staff for the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 This draft guidance is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
(). 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