View all text of Subpart F [§ 884.5050 - § 884.5980]
§ 884.5400 - Menstrual cup.
(a) Identification. A menstrual cup is a receptacle placed in the vagina to collect menstrual flow.
(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.