Medical Devices; 30-Day Notices and 135-Day PMA Supplement Review
fda-device · Food and Drug Administration · Rule · Published 1998-08-11 · 63 FR 42699
Document
Document number
98-21470
Federal Register citation
63 FR 42699
CFR reference
21 CFR 814
Type
Rule
Action
Direct final rule; withdrawal.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
1998-08-11
HHS docket
Docket No. 98N-0168
Abstract
The Food and Drug Administration (FDA) published, in the Federal Register of April 27, 1998 (63 FR 20530), a direct final rule to implement the amendments to the premarket approval provisions of the Federal Food, Drug, and Cosmetic Act, as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). The comment period closed on July 13, 1998. FDA is withdrawing the direct final rule because the agency received significant adverse comment.