---
kind: "section"
citation: "21 C.F.R. § 801.20"
title: "21"
number: "801.20"
heading: "Label to bear a unique device identifier."
url: "https://uscodex.org/cfr/21/801.20"
---

# §801.20. Label to bear a unique device identifier.

- (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](/cfr/21/part830.md) of this chapter.
  - (2) Every device package shall bear a UDI that meets the requirements of this subpart and [part 830](/cfr/21/part830.md) of this chapter.
- (b) **Exceptions.** Exceptions to the general rule of [paragraph (a)](#a) of this section are provided by §§ [801.30](/cfr/21/801.30.md), [801.45](/cfr/21/801.45.md), and [801.128(f)(2)](/cfr/21/801.128.md?p=f-2), and [§ 801.55](/cfr/21/801.55.md) provides a means to request an exception or alternative not provided by those provisions.

## Notes

### Amendments

[78 FR 58818, Sept. 24, 2013]

### 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]