21 CFR 801.87
21 CFR 801.87 is the regulation in 21 CFR Part 801, Labeling. 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
What FDA writes when it cites it
The finding headings that cite 21 CFR 801.87 most often, as written in the letters.
- 1 letterAdditionally, as described in the indications for use statement above, the External Counterpulsation System Model, Soulaire cleared in K202108 is “*intended for use under the oversight of a healthcare professional*”.…
- 1 letterFDA has reviewed your firm’s website, https://www.soulaire.com/, and determined that the ECP System Model: Soulaire is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does…
- 1 letterThe above statements describe device intended uses for the External Counterpulsation System Model, Soulaire that differ significantly from those cleared in K202108 and constitute major changes or modifications to the…
The regulation
The text of this section is not in the saved copy.
Text from eCFR.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 801.87.
Latest letters citing it
The letter citing 21 CFR 801.87 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.