21 CFR 830.50
§ 830.50 Changes that require use of a new device identifier.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 830.50, § 830.50 Changes that require use of a new device identifier, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88971
- Permanent ID
ys:prov:88971@1- SHA-256
251b47818c3d5f27d36d0545e54cb9892c9530654d98fd3744f5343a2099dab4
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.