UDI Compliance Dates Extended for Class I Medical Devices

06/06/17

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08h00 - 16h30

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On June 2, 2017, the U.S. Food and Drug Administration (FDA) published a letter stating that they plan on issuing a guidance document extending the Unique Device Identifier (UDI) enforcement dates for Class I and Unclassified medical devices that are not implantable, life-supporting, or life sustaining.

The compliance date will be extended by two years – from September 24, 2018 to September 24, 2020 for labels, GUDID submissions, and standard date format requirements and will be extended from September 24, 2020 to September 24, 2022 for direct marking requirements.

Click to view the letter:
https://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM561575.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

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