21 CFR 807.39
Misbranding by reference to establishment registration or to registration number
21 CFR 807.39 is the regulation titled “Misbranding by reference to establishment registration or to registration number” in 21 CFR Part 807, Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices. Since 2021, 13 FDA warning letters have cited it.
- Letters citing it
- 13 since 2021
- Jan 1 to Oct 30, 2026
- 1 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 807.81, in 1 letter
- Closed out
- 54% 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.
What FDA writes when it cites it
The finding headings that cite 21 CFR 807.39 most often, as written in the letters.
- 1 letterDisplaying a “Certificate of FDA Registration” issued by “UCL-REGSERVICE INC” (UCL-REGSERVICE Certificate) alongside Arun KN95 Folding Face Mask product information
- 1 letterDisplaying a “Certification of Registration” issued by “Sungo Technical Services Inc.” (Sungo Technical Certificate) alongside Deming Surgical Mask product information
- 1 letterDisplaying a “Certification of Registration” issued by “Wayborn Quality & Technology Services” (Wayborn Certificate) alongside the BLUE – Pairon 3Ply Face Mask product information
The regulation
Read the text of 21 CFR 807.39 (eCFR, as of Sep 1, 2026)
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.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 807.39.
Latest letters citing it
The 3 letters citing 21 CFR 807.39 that FDA posted most recently.
- DevicesView Skytron, LLCUVC disinfection devices for healthcare environments and medical equipmentIssuedMay 19, 2026PostedJul 7, 2026
- DevicesView Pairon Solutions LLCFace masks (KN95, surgical, and 3-ply)IssuedAug 9, 2021PostedOct 5, 2021
- DevicesView Fixture Display LLCKN95 face masks and 3-ply surgical masksIssuedJun 28, 2021PostedJul 6, 2021
Put this kind of reading to
work on your own records.
Botable builds and runs a custom AI layer around the software you already use, so your team can do the job you hired them for.
Counts include every citation in a letter, as the Letters filter does. How this database is built.