21 C.F.R. § 884.5400

Current through October 31, 2024
Section 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 .

21 C.F.R. §884.5400

45 FR 12684, Feb. 26, 1980, as amended at 84 FR 71816 , Dec. 30, 2019