§ 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.

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Warning letters citing § 830.50

1 FDA warning letters since 2017 cite this section :

• Forcemech International LLC 21 Sept 2022

FDA guidance that cites § 830.50

• Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions: Guidance for Industry and Food and Drug Administration Staff 18 Aug 2025
• Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff draft 7 Jan 2025
• Global Unique Device Identification Database (GUDID): Guidance for Industry and Food and Drug Administration Staff 17 Dec 2024
• Predetermined Change Control Plans for Medical Devices: Draft Guidance for Industry and FDA Staff draft 22 Aug 2024
• Unique Device Identification: Convenience Kits : Guidance for Industry and Food and Drug Administration Staff 26 Apr 2019
• Unique Device Identification: Direct Marking of Devices : Guidance for Industry and Food and Drug Administration Staff 17 Nov 2017
• Unique Device Identifier System: Frequently Asked Questions, Vol. 1 : Guidance for Industry and Food and Drug Administration Staff 20 Aug 2014

Amendment history

Federal Register documents that created or amended this section.

• 78 FR 58825 24 Sept 2013