21 CFR 884.5400 - Menstrual cup.

Regulations last checked for updates: Oct 17, 2024

Title 21 - Food and Drugs last revised: Oct 15, 2024

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.

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

authority: 21 U.S.C. 351,360,360c,360e,360j,360

source: 45 FR 12684, Feb. 26, 1980, unless otherwise noted.

cite as: 21 CFR 884.5400