fda-device · Food and Drug Administration · Rule · Published 1996-11-20 · Effective 1997-05-19 · 61 FR 59004
Document
Document number
96-29695
Federal Register citation
61 FR 59004
CFR reference
21 CFR 810
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
1996-11-20
Effective date
1997-05-19
HHS docket
Docket No. 93N-0260
Abstract
The Food and Drug Administration (FDA) is establishing procedures for implementing the medical device recall authority provided in the Safe Medical Devices Act of 1990 (the SMDA). This statutory authority protects the public health by permitting FDA to remove dangerous devices from the market promptly. This authority complements other provisions of the device law, including tracking and notification.