21 C.F.R. § 884.5970 Clitoral engorgement device.
Title 21 - Food and Drugs
(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.” [65 FR 47306, Aug. 2, 2000]
Title 21: Food and Drugs
PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES
Subpart F—Obstetrical and Gynecological Therapeutic Devices
§ 884.5970 Clitoral engorgement device.
