21 CFR 801.20
Label to bear a unique device identifier
21 CFR 801.20 is the regulation titled “Label to bear a unique device identifier” in 21 CFR Part 801, Labeling. Since 2021, 24 FDA warning letters have cited it.
- Letters citing it
- 24 since 2021
- Jan 1 to Oct 30, 2026
- 5 against 8 on the same dates in 2025
- Most often cited with
- 21 CFR 830.300, in 22 letters
- Closed out
- 17% of these letters have a published close-out
Letters citing it, by year issued
Most are medical device letters (23 of 24). 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 801.20 most often, as written in the letters.
- 1 letterFailure to ensure that the label of every medical device shall bear a UDI that meets the requirements of 21 CFR part 801, subpart B, and 21 CFR part 830, as required by 21 CFR 801.20(a). For example,
- 1 letterFailure to ensure that the label of every medical device shall bear a unique device identifier (UDI) that meets the requirements of 21 CFR 801 Subpart B and 21 CFR Part 830, as required by 21 CFR 801.20(a)
- 1 letterFailure to Have Compliant Labeling
The regulation
Read the text of 21 CFR 801.20 (eCFR, as of Sep 1, 2026)
(a) In general. (1) The label of every medical device shall bear a unique device identifier (UDI) that meets the requirements of this subpart and part 830 of this chapter.
(2) Every device package shall bear a UDI that meets the requirements of this subpart and part 830 of this chapter.
(b) Exceptions. Exceptions to the general rule of paragraph (a) of this section are provided by §§ 801.30, 801.45, and 801.128(f)(2), and § 801.55 provides a means to request an exception or alternative not provided by those provisions.
[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 801.20.
- 21 CFR 830.300Devices subject to device identification data submission requirements22 letters cite both
- 21 CFR 830.3Definitions21 letters cite both
- 21 CFR 801.3Definitions18 letters cite both
- 21 CFR 807.81When a premarket notification submission is required17 letters cite both
- 21 CFR 801.40Form of a unique device identifier16 letters cite both
- 21 CFR 820.30Design controls16 letters cite both
- 21 CFR 820.198Complaint files15 letters cite both
- 21 CFR 820.100Corrective and preventive action13 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 801.20 that FDA posted most recently.
- DevicesView Peter Schiff Enterprisescardiac electrode pads and AC cardiac fibrillatorsIssuedAug 26, 2026PostedOct 27, 2026
- DevicesView Specialty Health Products CO, LLCHydro-San Colonic Irrigation System (also known as Hydro-San Plus, Hydro-San, and Hydro-San Plus A Base Unit), the Aqua Cleanse Colonic…IssuedJul 7, 2026PostedSep 22, 2026
- DevicesView Nipro Renal Solutions USA, CorporationDry and liquid hemodialysis dialysate concentrate solutionsIssuedJul 24, 2026PostedAug 18, 2026
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Counts include every citation in a letter, as the Letters filter does. How this database is built.