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FDA Updates Guidance On Unique Device Identification Labeling For Class I Devices

 
• By Brian Bossetta

The US FDA’s most recent guidance revises UDI requirements for class I and unclassified medical devices the agency issued in July. Class I devices categorized as consumer health products will be exempt from some submission requirements.

FDA HQ
• Source: Alamy

The Food and Drug Administration has issued updated guidelines for labeling of class I devices, which partially revises guidance the agency issued on 1 July 2020.

The new draft guidance issued 14 October specifically updates the agency’s policy on Unique Device Identification (UDI) labeling.

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