21 C.F.R. § 884.5970

Current through October 31, 2024
Section 884.5970 - Clitoral engorgement device
(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."

21 C.F.R. §884.5970

65 FR 47306 , Aug. 2, 2000