fda-device · Food and Drug Administration · Rule · Published 1998-07-31 · Effective 1998-07-31 · 63 FR 40825
Document
Document number
98-20594
Federal Register citation
63 FR 40825
CFR reference
21 CFR 814
Type
Rule
Action
Direct final rule; withdrawal.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
1998-07-31
Effective date
1998-07-31
HHS docket
Docket No. 98N-0171
Abstract
The Food and Drug Administration (FDA) published, in the Federal Register of April 17, 1998 (63 FR 19185), a direct final rule to implement the amendments to the humanitarian use devices provision of the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). The comment period closed July 1, 1998. FDA is withdrawing the direct final rule because the agency received significant adverse comment.