21 C.F.R. § 884.5400
Menstrual cup.
Cite as 21 C.F.R. § 884.5400 (2026)
(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.
[45 FR 12684, Feb. 26, 1980, as amended at 84 FR 71816, Dec. 30, 2019]
- Cross-references to the CFR
- 884.9.