Under pressure from manufacturers, the FDA is pushing back Unique Device Identification (UDI) compliance deadlines for some non-sterile, class I, and unclassified devices.
Devicemakers will have until September 24, 2020 before they must comply with standard date formatting, labeling and Global Unique Device Identification Database (GUDID) data submission requirements for these devices, according to the new guidance, published in the Federal Register Nov. 5. Manufacturers will also have until Sept. 24, 2022 before they must comply with direct-mark requirements for these devices.
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