21 CFR 830.300: Devices subject to device identification data submission requirements
Requires labelers to submit device identification data for each version or model required to bear a UDI, allows voluntary submission otherwise, and lets FDA reject or remove nonconforming, ineligible, unapproved, banned, or suspended-issuer data.
Part 830, Unique Device Identification · Subpart E, Global Unique Device Identification Database
How FDA words it
The opening lines investigators use most when they cite 830.300, from the 483s we hold.
The information required by the Global Unique Device Identification Database for each medical device version or model required to bear a unique device identifier (UDI) was not provided.Most used
Cited over time
483s citing 830.300, by yearMost citations in 2024. Bars are relative to the busiest year. *2026 to date.
Years shown: 2017 to 2026. The busiest year was 2024.
Recent 483s citing 830.300
- BURTON MEDICAL · Addison, IllinoisThe information required by the Global Unique Device Identification Database for… Feb 20, 2026
- Seniorlife Technologies Inc · Bellevue, WashingtonA system to assign unique device identification (UDI) to the medical device was not… Feb 20, 2026
- Seniorlife Technologies Inc. · Bellevue, WashingtonA system to assign unique device identification (UDI) to the medical device was not… Feb 20, 2026
- Form 483 · FEI 3002619777 · Eagan, MinnesotaThe information required by the Global Unique Device Identification Database for… Feb 9, 2026
- Expanse Medical Inc. · Pleasanton, CaliforniaThe information required by the Global Unique Device Identification Database for… Jan 15, 2026
The regulation text
§ 830.300 Devices subject to device identification data submission requirements.
(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.
Questions
What does 21 CFR 830.300 require?
Requires labelers to submit device identification data for each version or model required to bear a UDI, allows voluntary submission otherwise, and lets FDA reject or remove nonconforming, ineligible, unapproved, banned, or suspended-issuer data.
How do FDA investigators word a 830.300 observation?
The most common opening is: “The information required by the Global Unique Device Identification Database for each medical device version or model required to bear a unique device identifier (UDI) was not provided.”
Which sections are cited alongside 830.300?
In the same 483s, investigators most often also cite 820.50 (Purchasing controls), 820.30 (Design controls), 820.100 (Corrective and preventive action), 820.198 (Complaint files).