---
kind: "section"
citation: "21 C.F.R. § 801.45"
title: "21"
number: "801.45"
heading: "Devices that must be directly marked with a unique device identifier."
url: "https://uscodex.org/cfr/21/801.45"
---

# §801.45. Devices that must be directly marked with a unique device identifier.

- (a) **In general.** A device that must bear a unique device identifier (UDI) on its label must also bear a permanent marking providing the UDI on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.
- (b) **UDI for direct marking.** The UDI provided through a direct marking on a device may be:
  - (1) Identical to the UDI that appears on the label of the device, or
  - (2) A different UDI used to distinguish the unpackaged device from any device package containing the device.
- (c) **Form of a UDI when provided as a direct marking.** When a device must bear a UDI as a direct marking, the UDI may be provided through either or both of the following:
  - (1) Easily readable plain-text;
  - (2) Automatic identification and data capture (AIDC) technology, or any alternative technology, that will provide the UDI of the device on demand.
- (d) **Exceptions.** The requirement of [paragraph (a)](#a) of this section shall not apply to any device that meets any of the following criteria:
  - (1) Any type of direct marking would interfere with the safety or effectiveness of the device;
  - (2) The device cannot be directly marked because it is not technologically feasible;
  - (3) The device is a single-use device and is subjected to additional processing and manufacturing for the purpose of an additional single use.
  - (4) **The device has been previously marked under paragraph (a) of this section.**
- (e) **Exception to be noted in design and development files.** A labeler that decides to make use of an exception under [paragraph (d)](#d) of this section must document the basis of that decision in the design and development files required by [§ 820.10(c)](/cfr/21/820.10.md?p=c) of this chapter.

## Notes

### Amendments

[78 FR 58818, Sept. 24, 2013, as amended at 90 FR 55979, Dec. 4, 2025]

### Authority

Authority: 21 U.S.C. 321, 331-334, 351, 352, 360d, 360i, 360j, 371, 374.

### Source

Source: 41 FR 6896, Feb. 13, 1976, unless otherwise noted.

### Amendments

[78 FR 58818, Sept. 24, 2013, as amended at 90 FR 55979, Dec. 4, 2025]