Changes that require use of a new device identifier.

21 C.F.R. § 830.50
in effectEffective: 2024-07-01
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(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.

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