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Medical Devices; Baseline Reports;
Stay of Effective Date

Federal Register: July 31, 1996 (Volume 61, Number 148)]
[Rules and Regulations]
[Page 39868-39869]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 803

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

Medical Devices; Medical Device Reporting; Baseline Reports; Stay of Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

SUMMARY: In response to numerous requests for the Food and Drug Administration (FDA) to further consider comments concerning manufacturer medical device reporting (MDR) baseline reporting requirements, FDA is staying the effective date of certain portions of the baseline reporting requirements. The stay of these requirements will allow FDA to further evaluate the issues raised by the comments and to determine whether the requirements should be revised.

Updated 12/10/1996

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