21 CFR 884.5970
§ 884.5970 Clitoral engorgement device.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 884.5970, § 884.5970 Clitoral engorgement device, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90868
- Permanent ID
ys:prov:90868@1- SHA-256
41269618f011052bb83965bbf8b00f27f0898d4b13309e101c544fe053cd9274
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Full text
(a) Identification. A clitoral engorgement device is designed to apply a vacuum to the clitoris. It is intended for use in the treatment of female sexual arousal disorder.
(b) Classification. Class II (special controls). The special control is a guidance document entitled: “Guidance for Industry and FDA Reviewers: Class II Special Controls Guidance Document for Clitoral Engorgement Devices.”
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.