Obstetrical and Gynecological Devices; Classification of Female Condoms
Information
Type
Rule
Regulated products
Medical Devices
Published
May 18, 2000
Last updated
May 18, 2000
Description
Document number 00-12526. 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.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)