Obstetrical and Gynecological Devices; Classification of Female Condoms
fda-device · Food and Drug Administration · Rule · Published 2000-05-18 · Effective 2000-06-19 · 65 FR 31454
Document
Document number
00-12526
Federal Register citation
65 FR 31454
CFR reference
21 CFR 884
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2000-05-18
Effective date
2000-06-19
HHS docket
Docket No. 99N-1309
Abstract
The Food and Drug Administration (FDA) is classifying the preamendments female condom intended for contraceptive and prophylactic purposes. Under this rule, the preamendments female condom is being classified into class III (premarket approval). This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the FDA Modernization Act of 1997.