fda-device · Food and Drug Administration · Rule · Published 1998-11-03 · Effective 1999-02-01 · 63 FR 59217
Document
Document number
98-29391
Federal Register citation
63 FR 59217
CFR reference
21 CFR 814
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
1998-11-03
Effective date
1999-02-01
HHS docket
Docket No. 98N-0171
Abstract
The Food and Drug Administration (FDA) is issuing a final rule amending the regulations governing humanitarian use devices (HUD's). 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).