Are You Affected by the US FDA Class I Deadline? Plan Early for UDI Requirements
Is your organization manufacturing devices classified as ‘class I’? Class I devices and devices that have not been classified into class I, class II or class III that are required to be labeled with a UDI code, must submit product data to the FDA’s GUDID by September 24, 2022 (moved from September 24, 2020). FDA announced a two-year shift of the enforcement of this compliance date on June 30, 2020.
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