Medical Devices; Medical Device User Facility and Manufacturer Reporting, Certification and Registration; Office of Management and Budget Approval; Extension of Effective Date
fda-device · Food and Drug Administration · Rule · Published 1996-04-11 · Effective 1996-07-31 · 61 FR 16043
Document
Document number
96-8970
Federal Register citation
61 FR 16043
CFR reference
21 CFR 803
Type
Rule
Action
Final rule; notification of approval of information collection requirements.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
1996-04-11
Effective date
1996-07-31
HHS docket
Docket No. 91N-0295
Abstract
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).