---
kind: "section"
citation: "21 C.F.R. § 830.300"
title: "21"
number: "830.300"
heading: "Devices subject to device identification data submission requirements."
url: "https://uscodex.org/cfr/21/830.300"
---

# §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](/cfr/21/801.40.md), 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](/cfr/21/830.20.md);
  - (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](/cfr/21/516.md) 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.

## Notes

### Source

Source: 78 FR 58826, Sept. 24, 2013, unless otherwise noted.

### Authority

Authority: 21 U.S.C. 321, 331, 352, 353, 360, 360d, 360i, 360j, 371.

### Source

Source: 78 FR 58823, Sept. 24, 2013, unless otherwise noted.