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Medical Devices User Facility and Manufacturer Reporting, Certification and Registration

[Federal Register: April 11, 1996 (Volume 61, Number 71)]
[Rules and Regulations]               
[Page 16043-16045]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 803 and 807

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

 
Medical Devices; Medical Device User Facility and Manufacturer 
Reporting, Certification and Registration; Office of Management and 
Budget Approval; Extension of Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; notification of approval of information collection 
requirements.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
Office of Management and Budget (OMB) has approved the collection of 
information requirements in the final rule on medical device user 
facility and manufacturer reporting, certification and registration. In 
addition, FDA is extending to July 31, 1996, the effective date of the 
final rule in response to requests and in order to allow sufficient 
time for user facilities and manufacturers to implement procedures to 
comply with the final rule. The final rule was published in the Federal 
Register of December 11, 1995 (60 FR 63578).

Updated 11/29/1996

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