Medical Device Reporting: Manufacturer Reporting, Importer Reporting, User Facility Reporting, Distributor Reporting
fda-device · Food and Drug Administration · Rule · Published 2000-01-26 · 65 FR 4112
Document
Document number
00-1785
Federal Register citation
65 FR 4112
CFR reference
21 CFR 803
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2000-01-26
HHS docket
Docket No. 98N-0170
Abstract
The Food and Drug Administration (FDA) is amending its regulations governing reporting by manufacturers, importers, distributors and health care (user) facilities of adverse events related to medical devices. 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).