21 CFR § 830.50 - Changes that require use of a new device identifier.

---
identifier: "/us/cfr/t21/s830.50"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 830.50 - Changes that require use of a new device identifier."
title_number: 21
title_name: "Food and Drugs"
section_number: "830.50"
section_name: "Changes that require use of a new device identifier."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "830"
part_name: "UNIQUE DEVICE IDENTIFICATION"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 331, 352, 353, 360, 360d, 360i, 360j, 371."
regulatory_source: "78 FR 58823, Sept. 24, 2013, unless otherwise noted."
cfr_part: "830"
---


# 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.

[78 FR 58825, Sept. 24, 2013]