§884.5400. Menstrual cup.
21 C.F.R. § 884.5400
Identification. A menstrual cup is a receptacle placed in the vagina to collect menstrual flow.
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.
Notes, amendments, and revision history
Amendments
[45 FR 12684, Feb. 26, 1980, as amended at 84 FR 71816, Dec. 30, 2019]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l , 371.
Source
Source: 45 FR 12684, Feb. 26, 1980, unless otherwise noted.
Amendments
[45 FR 12684, Feb. 26, 1980, as amended at 84 FR 71816, Dec. 30, 2019]