21 CFR 830.300
Devices subject to device identification data submission requirements
21 CFR 830.300 is the regulation titled “Devices subject to device identification data submission requirements” in 21 CFR Part 830, Unique Device Identification. Since 2021, 24 FDA warning letters have cited it.
- Letters citing it
- 24 since 2021
- Jan 1 to Oct 30, 2026
- 5 against 7 on the same dates in 2025
- Most often cited with
- 21 CFR 801.20, 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 830.300 most often, as written in the letters.
- 1 letterFailure to ensure that the labeler of a device provide the information required by the subpart for each version or model required to bear a unique device identifier, as required by 21 CFR 830.300
- 1 letterFailure to provide required information to Global Unique Device Identification Database (GUDID) as required by 21 CFR 830.300(a)
- 1 letterFailure to provide required information to GUDID as required by 21 CFR 830.300(a). For example:
The regulation
Read the text of 21 CFR 830.300 (eCFR, as of Sep 1, 2026)
(a) In general. The labeler of a device must provide the information required by this subpart for each version or model required to bear a unique device identifier (UDI).
(b) Voluntary submission of information. If a labeler voluntarily includes a UDI on the label of a device under § 801.40, the labeler may also voluntarily submit information concerning that device under this part.
(c) Exclusions. FDA may reject or remove any device identification data where:
(1) The device identifier submitted does not conform to § 830.20;
(2) The information concerns a device that is neither manufactured in the United States nor in interstate commerce in the United States,
(3) The information concerns a product that FDA determines is not a device or a combination product that includes a device constituent part,
(4) The information concerns a device or a combination product that requires, but does not have, FDA premarket approval, licensure, or clearance;
(5) A device that FDA has banned under section 516 of the Federal Food, Drug, and Cosmetic Act; or
(6) FDA has suspended the accreditation of the issuing agency that operates the system used by the labeler.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 830.300.
- 21 CFR 801.20Label to bear a unique device identifier22 letters cite both
- 21 CFR 830.3Definitions22 letters cite both
- 21 CFR 807.81When a premarket notification submission is required17 letters cite both
- 21 CFR 820.30Design controls17 letters cite both
- 21 CFR 801.3Definitions16 letters cite both
- 21 CFR 820.198Complaint files16 letters cite both
- 21 CFR 801.40Form of a unique device identifier14 letters cite both
- 21 CFR 820.100Corrective and preventive action12 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 830.300 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.