The compliance date for unique device identifier requirements for Class I and unclassified medical devices has been extended by the FDA from Sept. 24, 2018, to Sept. 24, 2020, and for direct mark requirements from Sept. 24, 2020, to Sept. 24, 2022. The extensions were made in response to industry concerns about meeting compliance dates, as well as to resolve issues regarding higher-risk devices before lower-risk devices are added to the UDI system.
FDA extends UDI compliance dates for Class I, unclassified devices
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