Title 21: Food and Drugs
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/ PART 830 - UNIQUE DEVICE IDENTIFICATION
/ Subpart B - Requirements for a Unique Device Identifier / § 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.