21 CFR 801.40
Form of a unique device identifier
21 CFR 801.40 is the regulation titled “Form of a unique device identifier” in 21 CFR Part 801, Labeling. Since 2021, 16 FDA warning letters have cited it.
- Letters citing it
- 16 since 2021
- Jan 1 to Oct 30, 2026
- 3 against 5 on the same dates in 2025
- Most often cited with
- 21 CFR 801.20, in 16 letters
- Closed out
- 19% 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 801.40 most often, as written in the letters.
- 1 letterThe labels and packages of the Banda-SiL products do not bear such a UDI
- 1 letterThe labels of the welloStationX devices do not bear such a UDI
The regulation
Read the text of 21 CFR 801.40 (eCFR, as of Sep 1, 2026)
(a) Every unique device identifier (UDI) must meet the technical requirements of § 830.20 of this chapter. The UDI must be presented in two forms:
(1) Easily readable plain-text, and
(2) Automatic identification and data capture (AIDC) technology.
(b) The UDI must include a device identifier segment. Whenever a device label includes a lot or batch number, a serial number, a manufacturing date, an expiration date, or for a human cell, tissue, or cellular or tissue-based product (HCT/P) regulated as a device, a distinct identification code as required by § 1271.290(c) of this chapter, the UDI must include a production identifier segment that conveys such information.
(c) If the AIDC technology is not evident upon visual examination of the label or device package, the label or device package must disclose the presence of AIDC technology.
(d) A class I device that bears a Universal Product Code (UPC) on its label and device packages is deemed to meet all requirements of subpart B of this part. The UPC will serve as the unique device identifier required by § 801.20.
[78 FR 58818, Sept. 24, 2013]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 801.40.
- 21 CFR 801.20Label to bear a unique device identifier16 letters cite both
- 21 CFR 801.3Definitions16 letters cite both
- 21 CFR 830.3Definitions14 letters cite both
- 21 CFR 830.300Devices subject to device identification data submission requirements14 letters cite both
- 21 CFR 807.81When a premarket notification submission is required11 letters cite both
- 21 CFR 820.198Complaint files10 letters cite both
- 21 CFR 820.100Corrective and preventive action9 letters cite both
- 21 CFR 820.30Design controls9 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 801.40 that FDA posted most recently.
- DevicesView Peter Schiff Enterprisescardiac electrode pads and AC cardiac fibrillatorsIssuedAug 26, 2026PostedOct 27, 2026
- DevicesView Nipro Renal Solutions USA, CorporationDry and liquid hemodialysis dialysate concentrate solutionsIssuedJul 24, 2026PostedAug 18, 2026
- DevicesView Physitemp Instruments, LLCClinical Electronic Thermometers (TH-5; TH-5/AOP; TH-8; TH-8/AOP), Clinical Temperature Monitoring Probes (OT-1; ESO-1; RET-1; SST-1;…IssuedNov 12, 2025PostedMar 31, 2026
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Counts include every citation in a letter, as the Letters filter does. How this database is built.