21 CFR § 884.5400
Menstrual cup
June 25, 2020
(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]
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