June 12, 2017
FDA extends UDI compliance dates for Class I, unclassified devices
Editor's Note
The Food and Drug Administration (FDA) has notified medical device labelers that the compliance dates for unique device identifier (UDI) requirements for Class I and unclassified medical devices has been extended from September 24, 2018, to September 24, 2020, and for direct mark requirements from September 24, 2020, to September 24, 2022.
The extensions were made in response to industry concerns about meeting compliance dates and to resolve higher-risk device issues before adding lower-risk devices to the UDI system.
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