Medical Devices; Establishment Registration and Device Listing for Manufacturers and Distributors of Devices
fda-device · Food and Drug Administration · Rule · Published 1998-09-29 · Effective 1999-02-11 · 63 FR 51825
Document
Document number
98-25796
Federal Register citation
63 FR 51825
CFR reference
21 CFR 807
Type
Rule
Action
Direct final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
1998-09-29
Effective date
1999-02-11
HHS docket
Docket No. 98N-0520
Abstract
The Food and Drug Administration (FDA) is amending certain regulations governing establishment registration and device listing by domestic distributors. These amendments are being made to implement revisions to the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Food and Drug Modernization Act of 1997 (FDAMA). Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule, under FDA's usual procedures for notice and comment, to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comment and withdraws the direct final rule.