# Obstetrical and Gynecological Devices; Classification of Female Condoms
> **Food and Drug Administration** · Final rule. · Published 2000-05-18 · Effective 2000-06-19 · 65 FR 31454
## Document
- **Document number:** 00-12526
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 65 FR 31454
- **CFR reference:** 21 CFR 884
- **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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2000/05/18/00-12526/obstetrical-and-gynecological-devices-classification-of-female-condoms)
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