21 C.F.R. § 884.5350
Contraceptive diaphragm and accessories.
Cite as 21 C.F.R. § 884.5350 (2026)
(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).