Medical Device Reporting: Manufacturer Reporting, Importer Reporting, User Facility Reporting, Distributor Reporting
fda-device · Food and Drug Administration · Rule · Published 1998-08-27 · 63 FR 45716
Document
Document number
98-22926
Federal Register citation
63 FR 45716
CFR reference
21 CFR 803
Type
Rule
Action
Direct final rule; withdrawal.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
1998-08-27
HHS docket
Docket No. 98N-0170
Abstract
The Food and Drug Administration (FDA) published in the Federal Register of May 12, 1998, a proposed rule (63 FR 26129) and a direct final rule (63 FR 26069) to implement amendments to the medical device reporting provisions of the Federal Food, Drug, and Cosmetic Act, as amended by the FDA Modernization Act of 1997 (FDAMA). The comment period closed July 27, 1998. FDA is withdrawing the direct final rule because the agency received significant adverse comment.