StacksVerified U.S. regulatory reference

21 CFR §830.60

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
If you relabel a device that is required to bear a unique device identifier (UDI), you must:
  1. (a)Assign a new device identifier to the device, and
  2. (b)Keep a record showing the relationship of the prior device identifier to your new device identifier.