Medical Devices; Reports of Corrections and Removals; Stay of Effective Date of Information Collection Requirements
fda-device · Food and Drug Administration · Rule · Published 1997-12-24 · Effective 1997-11-17 · 62 FR 67274
Document
Document number
97-33418
Federal Register citation
62 FR 67274
CFR reference
21 CFR 806
Type
Rule
Action
Stay of effective date of a final regulation.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
1997-12-24
Effective date
1997-11-17
HHS docket
Docket No. 91N-0396
Abstract
The Food and Drug Administration (FDA) is staying the effective date of the information collection requirements of a final rule to implement the provisions of the Safe Medical Devices Act of 1990 (the SMDA) regarding reports of corrections and removals of medical devices. FDA is taking this action because the information collection requirements in the final rule have not yet been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA). In the Federal Register of November 26, 1997, FDA announced that it sent the proposed information collection to OMB for review and clearance.