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Medical Devices; Stay of Effective Date;
Revocation of Final Rule

[Federal Register: July 23, 1996 (Volume 61, Number 142)]
[Rules and Regulations]
[Page 38345-38347]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[[Page 38345]]

Part III

Department of Health and Human Services

Food and Drug Administration

21 CFR Part 803, et al.

Medical Devices; Final and Proposed Rules

[[Page 38346]]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 803, 804, and 807

[Docket No. 91N-0295]-RIN 0910-AA09

Medical Devices; Medical Device Distributor and Manufacturer Reporting; Certification, Registration, Listing, and Premarket Notification Submission; Stay of Effective Date; Revocation of Final Rule

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

SUMMARY: In response to numerous requests for the Food and Drug Administration (FDA) to consider further comments concerning medical device reporting (MDR) certification and U.S. designated agent requirements, FDA is staying the effective date of these two specific provisions of the adverse event reporting final rule that was published in the Federal Register of December 11, 1995. Specifically, these provisions relate to manufacturer certification and U.S. designated agent requirements. In addition, for consistency purposes, FDA is revoking the distributor reporting certification requirement that went into effect on May 28, 1992.

Updated 12/10/1996

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