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Home » U.S. UDI Guidance Brings Calls for Timeline Extensions, Clarity
U.S. UDI Guidance Brings Calls for Timeline Extensions, Clarity
The U.S. Food and Drug Administration’s final guidance on unique device identification should allow for submission of UDI data elements within 10 days of commercializing a device, rather than requiring that they be in the Global UDI Database before market launch, AdvaMed says. The trade group warns that the higher hurdle could lead to lost sales.
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