fda-device · Food and Drug Administration · Rule · Published 2002-02-08 · Effective 2002-05-09 · 67 FR 5943
Document
Document number
02-3076
Federal Register citation
67 FR 5943
CFR reference
21 CFR 821
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2002-02-08
Effective date
2002-05-09
HHS docket
Docket No. 00N-1034
Abstract
The Food and Drug Administration (FDA) is amending the medical device tracking regulation. FDA is making substantive changes to revise the scope of the regulation and add certain patient confidentiality requirements, and nonsubstantive changes to remove outdated references and simplify terminology. These revisions are made to conform the regulation to changes made in section 519(e) of the Federal Food, Drug, and Cosmetic Act (the act) by the FDA Modernization Act of 1997 (FDAMA), and to simplify certain requirements.