21 CFR 884.5350 : Food And Drugs (§ 1.1 To Parts 1403-1499) — (Subpart A To Parts 1272-1299) — Food And Drug Administration, Department Of Health And Human Services (Continued) (Subpart A To Parts 1272-1299) — Medical Devices (Subpart A To § 898.14) — Obstetrical And Gynecological Devices (§ 884.1 To § 884.6200) — Obstetrical And Gynecological Therapeutic Devices (§ 884.5050 To § 884.5980) — Contraceptive diaphragm and accessories.

4 Aug 2016

(a) Identification. A contraceptive diaphragm is a closely fitting membrane placed between the posterior aspect of the pubic bone and the posterior vaginal fornix. The device covers the cervix completely and is used with a spermicide to prevent pregnancy. This generic type of device may include an introducer.

(b) Classification. Class II (performance standards).

21 CFR 884.5350