fda-device · Food and Drug Administration · Rule · Published 1998-04-17 · Effective 1998-08-31 · 63 FR 19185
Document
Document number
98-9637
Federal Register citation
63 FR 19185
CFR reference
21 CFR 814
Type
Rule
Action
Direct final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
1998-04-17
Effective date
1998-08-31
HHS docket
Docket No. 98N-0171
Abstract
The Food and Drug Administration (FDA) is amending the regulations governing humanitarian use devices. These amendments are being made to implement provisions of the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Food and Drug Administration 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.