Medical Devices; 30-Day Notices and 135-Day PMA Supplement Review
fda-device · Food and Drug Administration · Rule · Published 1998-10-08 · Effective 1998-11-09 · 63 FR 54042
Document
Document number
98-26928
Federal Register citation
63 FR 54042
CFR reference
21 CFR 814
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
1998-10-08
Effective date
1998-11-09
HHS docket
Docket No. 98N-0168
Abstract
The Food and Drug Administration (FDA) is amending its regulations governing the submission and review of premarket approval (PMA) supplements to provide for the submission of a 30-day notice for modifications to manufacturing procedures or methods of manufacture. Amendments are being made to implement revisions to the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA).