Obstetrical and gynecological devices; classification of female condoms. Food and Drug Administration, HHS. Final rule.
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.
D019111:Single-Use Internal Condom / Q000145:classification*; D005260:Female; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration