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.
21 CFR Part 801 · Labeling
§ 801.6 Medical devices; misleading statements
Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.
Warning letters citing § 801.6
2 FDA warning letters since 2017 cite this section :
- Steiner Biotechnology, LLC 19 May 2023
- Lexion Medical LLC 26 Jul 2021
FDA guidance that cites § 801.6
- Patient-Matched Guides for Orthopedic Implants: Guidance for Industry and Food and Drug Administration Staff 7 May 2026
- Device Labeling Guidance #G91-1 (Blue Book Memo) 7 Mar 1991
Amendment history
Federal Register documents that created or amended this section.
- 41 FR 6896 13 Feb 1976