other · Food and Drug Administration · Rule · Published 2002-06-06 · Effective 2002-07-08 · 67 FR 38878
Document
Document number
02-14100
Federal Register citation
67 FR 38878
CFR reference
21 CFR 822
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2002-06-06
Effective date
2002-07-08
HHS docket
Docket No. 00N-1367
Abstract
The Food and Drug Administration (FDA) is implementing the postmarket surveillance (PS) provisions of the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). The purpose of this rule is to provide for the collection of useful data about devices that can reveal unforeseen adverse events or other information necessary to protect the public health.