[Federal Register Volume 64, Number 155 (Thursday, August 12, 1999)]
[Notices]
[Page 44024]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-20885]
[[Page 44024]]
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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
Devices;'' 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availability of a revised draft guidance document entitled ``Draft
Compliance Program Guidance Manual: Inspection of Medical Devices.''
This revised draft compliance program provides guidance to FDA staff
for the enforcement of four medical device postmarket regulations: The
quality system (QS) regulation, which includes coverage of
sterilization process validation and the use of the guidance on quality
systems inspections technique (QSIT); medical device reporting (MDR);
medical device corrections and removals; and medical device tracking
requirements. This revised draft guidance is intended to represent the
agency's current thinking on the inspection of medical device
manufacturers, and it is neither final nor in effect at this time.
DATES: Written comments concerning this revised draft guidance must be
submitted by November 10, 1999.
ADDRESSES: See the SUPPLEMENTARY INFORMATION section for information on
electronic access to the revised draft guidance. Submit written
requests for single copies on a 3.5'' diskette of the draft guidance
entitled ``Draft Compliance Program Guidance Manual: Inspection of
Medical Devices'' 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. Submit written comments
concerning the revised draft guidance to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Allen T. Wynn, Center for Devices and
Radiological Health (HFZ-306), Food and Drug Administration, 2094
Gaither Rd., Rockville, MD 20850, 301-594-4695.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a revised draft guidance
entitled ``Draft Compliance Program Guidance Manual: Inspection of
Medical Devices'' (CP 7382.845). A notice of availability of the draft
guidance was published in the Federal Register of July 30, 1998 (63 FR
40720). The draft guidance provides guidance to the FDA field and
center staff on the inspection and enforcement activities related to
the QS/good manufacturing practices (GMP's) regulation (21 CFR part
820), the MDR regulation (21 CFR part 803), the medical device
corrections and removals regulation (21 CFR part 806), and the medical
device tracking requirements (21 CFR part 821).
The revised draft document contains the following three major
differences from the previous draft guidance. First, the QSIT should be
used to conduct QS/GMP inspections, including inspections for
sterilization processes, to evaluate a firm's manufacturing and QS.
Second, part V of the draft guidance document has been revised so that
an official action is indicated based on evidence of QS or subsystem(s)
deviations that constitute major nonconformities. Third, three
inspection programs have been added to cover the requirements of the
MDR, medical device corrections and removals, and the medical device
tracking regulations.
Inspection of MDR, medical device corrections and removals, and
medical device tracking requirements should be conducted during initial
or comprehensive inspections. If a subsequent routine or followup
inspection of a firm's corrective and preventive action subsystem
suggests a potential QS problem, then these three related regulatory
requirements should be assessed.
The agency has adopted 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 revised draft guidance
document is issued as a level 1 guidance consistent with GGP's.
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.
II. Electronic Access
In order to receive the ``Draft Compliance Program Guidance Manual:
Inspection of Medical Devices'' (CP7382.845) 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 the second voice prompt press 2, and then enter
the document number (1702), followed by the pound sign (#). Then follow
the remaining voice prompts to complete your request.
Persons interested in obtaining a copy of the revised 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 Devices'' (CP7382.845), 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''.
III. Comments
Interested persons may, on or before November 10, 1999, submit to
Dockets Management Branch (address above) written comments regarding
this revised draft guidance. 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 revised draft guidance and received
comments are available for public examination in the Dockets Management
Branch between 9 a.m. and 4 p.m., Monday through Friday.
Dated: July 28, 1999.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 99-20885 Filed 8-11-99; 8:45 am]
BILLING CODE 4160-01-F
