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21 CFR 884.5400

§ 884.5400 Menstrual cup.

United States · 21 CFR — Food and Drugs · Status: effective

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21 CFR 884.5400, § 884.5400 Menstrual cup, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90859
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Full text

(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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.