Title 21

SECTION 830.50

830.50 Changes that require use of a new device identifier.

§ 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]

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