21 CFR 830.60
§ 830.60 Relabeling of a device that is required to bear a unique device identifier.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 830.60, § 830.60 Relabeling of a device that is required to bear a unique device identifier, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88972
- Permanent ID
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Full text
If you relabel a device that is required to bear a unique device identifier (UDI), you must:
(a) Assign a new device identifier to the device, and
(b) Keep a record showing the relationship of the prior device identifier to your new device identifier.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.