Registration of a device establishment or assignment of a registration number does not in any way denote approval of the establishment or its products. Any representation that creates an impression of official approval because of registration or possession of a registration number is misleading and constitutes misbranding.
21 CFR Part 807 · Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices
§ 807.39 Misbranding by reference to establishment registration or to registration number
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 § 807.39
14 FDA warning letters since 2017 cite this section ; the most recent:
- Skytron, LLC 19 May 2026
- Pairon Solutions LLC 9 Aug 2021
- World Packaging Solutions, LLC 28 Jun 2021
- Fixture Display LLC 28 Jun 2021
- Zhejiang Xichen Medical Technology Co., Ltd. 4 Jun 2021
- Dongguan City Xinyuan Nonwoven Co., Ltd. 27 May 2021
- Irvin, Inc. 27 May 2021
- Mask Supply Store 21 May 2021
- BMHshop 26 Apr 2021
- Manhattan Stitching Company, Inc. 13 Apr 2021
- Ikcon Investments, Inc dba Ikcon Medical 25 Mar 2021
- Shenzhen Weifa Technology Co., Ltd 11 Mar 2021
FDA guidance that cites § 807.39
Amendment history
Federal Register documents that created or amended this section.
- 42 FR 42526 28 Aug 1977