[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]
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