21 CFR 884.5970
Clitoral engorgement device
21 CFR 884.5970 is the regulation titled “Clitoral engorgement device” in 21 CFR Part 884, Obstetrical and Gynecological Devices. Since 2021, 1 FDA warning letter has cited it.
- Letters citing it
- 1 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 807.81, in 1 letter
- Closed out
- 100% of these letters have a published close-out
Letters citing it, by year issued
It is a medical device letter. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
- 02021
- 02022
- 02023
- 12024
- 02025
- 02026
The regulation
Read the text of 21 CFR 884.5970 (eCFR, as of Sep 1, 2026)
(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]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 884.5970.
- 21 CFR 807.81When a premarket notification submission is required1 letter cites both
- 21 CFR 820.198Complaint files1 letter cites both
- 21 CFR 820.20Management responsibility1 letter cites both
- 21 CFR 820.22Quality audit1 letter cites both
- 21 CFR 820.30Design controls1 letter cites both
- 21 CFR 820.50Purchasing controls1 letter cites both
- 21 CFR 820.80Receiving, in-process, and finished device acceptance1 letter cites both
- 21 CFR 876.5020External penile rigidity devices1 letter cites both
Latest letters citing it
The letter citing 21 CFR 884.5970 that FDA posted most recently.
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Counts include every citation in a letter, as the Letters filter does. How this database is built.