---
kind: "section"
citation: "21 C.F.R. § 830.50"
title: "21"
number: "830.50"
heading: "Changes that require use of a new device identifier."
url: "https://uscodex.org/cfr/21/830.50"
---

# §830.50. Changes that require use of a new device identifier.

- (a) Whenever you make a change to a device that is required to bear a unique device identifier (UDI) on its label, and the change results in a new version or model, you must assign a new device identifier to the new version or model.
- (b) Whenever you create a new device package, you must assign a new device identifier to the new device package.

## Notes

### Amendments

[78 FR 58825, Sept. 24, 2013]

### 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.

### Amendments

[78 FR 58825, Sept. 24, 2013]
