Current through November 30, 2024
Section 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