[Federal Register Volume 60, Number 118 (Tuesday, June 20, 1995)]
[Notices]
[Page 32160]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-14947]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95D-0114]


Medical Devices; Premarket Notification (510(k)) Procedures/Good 
Manufacturing Practices; Compliance Program; 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 revisions to the standard compliance program for good 
manufacturing practices (GMP's) (Compliance Program 7382.830). These 
revisions are intended to refine and refocus FDA's compliance program 
linking GMP requirements with class I and II premarket notification 
(510(k)) submissions and other relevant applications. The revisions are 
being made as part of FDA's reinventing Government initiative and have 
been incorporated into ``Compliance Program 7382.830, Inspection of 
Medical Device Manufacturers,'' which supersedes the ``Medical Device 
Reference List'' procedures.

ADDRESSES: Submit written requests for single copies of the revisions 
to the Division of Small Manufacturers Assistance (DSMA) (HFZ-220), 
Center for Devices and Radiological Health, Food and Drug 
Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-443-6597 or 
1-800-638-2041. Requests should be identified with the docket number 
found in brackets in the heading of this document. Send two self-
addressed adhesive labels to assist the office in processing your 
requests. The revisions are available for public examination in the 
Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 
1-23, 12420 Parklawn Dr., Rockville, MD 20857, between 9 a.m. and 4 
p.m., Monday through Friday. Copies of a facsimile of the revision are 
available from CDRH Facts on Demand by requesting the following 
document numbers and their respective parts: 2702 (compliance program), 
3702 (attachment A), 4702 (attachment A-1), 5702 (attachment B through 
F), 6702 (attachment G), (1-800-899-0281). Copies of the revisions may 
also be obtained from the Electronic Docket administered by DSMA and 
available to any one with a video terminal or personal computer (1-800-
252-1366).

FOR FURTHER INFORMATION CONTACT: Marje A. Hoban, Center for Devices and 
Radiological Health (HFZ-306), Food and Drug Administration, 2094 
Gaither Rd., MD 20850, 301-594-4695.

SUPPLEMENTARY INFORMATION: In a letter dated April 7, 1995, the 
Director of the Center for Devices and Radiological Health advised 
registered medical device companies of changes that FDA was making to 
its compliance program linking class I and II 510(k) submissions with 
GMP requirements. These procedural changes became effective May 1, 
1995, and have been made part of the standard compliance program for 
GMP's (Compliance Program 7382.830). FDA is now making the revisions 
available in conjunction with the April 7, 1995, letter. The general 
framework of the restructured program incudes: (1) Criteria for linking 
GMP's with marketing clearance for class I or II (510(k)) devices; (2) 
procedures for notifying firms that clearance of their class I or II 
(510(k)) submission may be deferred due to serious, related GMP 
violations; (3) actions FDA will take to reply promptly to a firm's 
response to an FDA Form 483 and/or GMP Warning Letter; and (4) 
timeframes for agency action. The changes noted above also apply to PMA 
supplements that are not subject to the PMA preapproval inspection 
program, and to export certificates for legally marketed devices.
    These changes are being made as part of FDA's reinventing 
Government initiative. This compliance program supersedes the ``Medical 
Device Reference List'' announced in the Federal Register of October 
26, 1993 (58 FR 57614).

    Dated: June 12, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-14947 Filed 6-19-95; 8:45 am]
BILLING CODE 4160-01-F