Medical Devices; Humanitarian Use Devices; Lift of Stay of Effective Date
fda-device · Food and Drug Administration · Rule · Published 1997-07-16 · Effective 1997-07-16 · 62 FR 38026
Document
Document number
97-18596
Federal Register citation
62 FR 38026
CFR reference
21 CFR 814
Type
Rule
Action
Final rule; lift of stay of effective date.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
1997-07-16
Effective date
1997-07-16
HHS docket
Docket No. 91N-0404
Abstract
The Food and Drug Administration (FDA) is lifting a stay of the effective date of certain provisions in a final rule on humanitarian use devices. The Office of Management and Budget (OMB) has approved the collection of information requirements contained in the final rule, and they are now effective.