21 C.F.R. § 830.50

Current through October 31, 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.

21 C.F.R. §830.50

78 FR 58825 , Sept. 24, 2013