[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availability of a revised draft guidance document entitled ``Draft 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 This revised draft guidance is intended to represent the 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DATES: Written comments concerning this revised draft guidance must be 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electronic access to the revised draft guidance.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requests for single copies on a 3.5'' diskette of the draft guidance 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concerning the revised draft guidance to the Dockets Management Branch 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