StacksVerified U.S. regulatory reference

21 CFR §830.50

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (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.
  2. (b)Whenever you create a new device package, you must assign a new device identifier to the new device package.