View all text of Subpart B [§ 830.10 - § 830.60]

§ 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]