[Federal Register Volume 66, Number 26 (Wednesday, February 7, 2001)]
[Notices]
[Pages 9347-9348]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-3203]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1651]


Devices--Inspections of Medical Device Manufacturers Compliance 
Program Guidance Manual, CP 7382.845; 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 compliance program (CP) entitled ``Inspection of 
Medical Device Manufacturers.'' This CP is intended to help FDA 
components and industry comply with FDA's internal inspection and 
compliance processes concerning quality system/good manufacturing 
practice (QS/GMP) inspections of manufacturers of medical devices.

DATES: Submit written comments on this CP at any time.

ADDRESSES: Submit written requests for single copies of CP 7382.845 
``Inspections of Medical Device Manufacturers'' to the Freedom of 
Information Office (HFI-35), Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857. Copies of the CP may also be downloaded to a 
personal computer with access to the Internet. The Office of Regulatory 
Affairs (ORA) home page includes the CP and may be accessed at http://www.fda.gov/ora. The CP will be available on the compliance references 
page for ORA. Submit written comments on the CP to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Technical questions concerning 
inspections of medical device manufacturers: Denise D. Dion, Division 
of Emergency and Investigational Operations (HFC-130), Office of 
Regional Operations, Office of Regulatory Affairs, Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-5645, 
FAX 301-443-6919.
    Questions concerning regulatory actions and all comments: Wes W. 
Morgenstern, Division of Program Operations (HFZ-305), Office of 
Compliance, Center for Devices and Radiological Health, Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-4699, 
FAX 301-594-4715.

SUPPLEMENTARY INFORMATION: FDA has renumbered CP 7382.830 as CP 
7382.845 and revised it to reflect a change in the guidance on how a 
QS/GMP inspection of a medical device manufacturer should be conducted. 
The new inspectional method is known as the quality systems inspection 
technique. The revision to the CP also reflects changes in when FDA may 
consider a firm out of compliance with the medical device quality 
system regulation (21 CFR part 820).
    The CP is intended to provide policy and regulatory guidance to 
FDA's field and headquarters staff with regard to medical device 
manufacturer inspections. It also contains information that may be 
useful to the regulated industry and to the public.
    The CP is being issued as a guidance document and represents the 
agency's current thinking on the subject. It does not create or confer 
any rights for or on any person and does not operate to bind FDA or the 
public. FDA published a notice making a draft of the CP available for 
public comment in the Federal Register (64 FR 44024, August 12, 1999).
    The agency has adopted good guidance practice (GGP) regulations (65 
FR 56468, September 19, 2000) that set forth the agency's policies and 
procedures for the development, issuance, and use of guidance 
documents. This CP is issued as a level 1 guidance consistent with 
GGP's.
    Interested persons may submit to the Dockets Management Branch 
(address above) written comments regarding the CP entitled 
``Inspections of Medical Device Manufacturers'' at any time. Two copies 
of any comments are to be submitted, except individuals may submit one 
copy. Comments are to be identified with the docket number found in 
brackets in the heading of this document. A copy of the CP and

[[Page 9348]]

received comments may be seen in the Dockets Management Branch between 
9 a.m. and 4 p.m., Monday through Friday.

    Dated: January 22, 2001.
Ann M. Witt,
Acting Associate Commissioner for Policy.
[FR Doc. 01-3203 Filed 2-6-01; 8:45 am]
BILLING CODE 4160-01-F