The Food and Drug Administration (FDA) extended Class I and unclassified devices UDI requirements compliance date to September 24, 2020, originally scheduled for September 24, 2018.

However, for implantable, life-supporting or life-sustaining devices of all classes, even Class I and unclassified devices, the compliance date for all UDI requirements was September 24, 2015.

It should be noted that the FDA had already introduced the Unified Identification Code (UDI) Medical Devices implementation program in 2014 by progressively involving Class III and II device manufacturers. To date more than 1 million devices were included in the Global Unique Device Identification Database (GUDID).

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