21 CFR 801.6
Medical devices; misleading statements
21 CFR 801.6 is the regulation titled “Medical devices; misleading statements” in 21 CFR Part 801, Labeling. Since 2021, 2 FDA warning letters have cited it.
- Letters citing it
- 2 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 801.20, in 1 letter
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
All are medical device letters. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
The regulation
Read the text of 21 CFR 801.6 (eCFR, as of Sep 1, 2026)
Among representations in the labeling of a device which render such device misbranded is a false or misleading representation with respect to another device or a drug or food or cosmetic.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 801.6.
- 21 CFR 801.20Label to bear a unique device identifier1 letter cites both
- 21 CFR 801.3Definitions1 letter cites both
- 21 CFR 807.81When a premarket notification submission is required1 letter cites both
- 21 CFR 820.22Quality audit1 letter cites both
- 21 CFR 820.25Personnel1 letter cites both
- 21 CFR 820.30Design controls1 letter cites both
- 21 CFR 820.50Purchasing controls1 letter cites both
- 21 CFR 820.70Production and process controls1 letter cites both
Latest letters citing it
The 2 letters citing 21 CFR 801.6 that FDA posted most recently.
- DevicesView Steiner Biotechnology, LLCbone grafting materials including, the Socket Graft, Socket Graft Plus, Socket Graft Injectable, OsseoConduct, OsseoConduct Micron, Ridge…IssuedMay 19, 2023PostedJun 6, 2023
- DevicesView Lexion Medical LLCAP 50/30 Insufflator, Insuflow Port, and Pneuview XEIssuedJul 26, 2021PostedAug 3, 2021
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Counts include every citation in a letter, as the Letters filter does. How this database is built.