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Home » Industry Seeks Extensions, Clarity In Final Version of UDI Guidance
Industry Seeks Extensions, Clarity In Final Version of UDI Guidance
The FDA’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, as the stricter requirement could lead to lost sales, AdvaMed says.