Industry Seeks Extensions, Clarity In Final Version of UDI Guidance

Devices & Diagnostics Letter
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.

To View This Article:


Buy This Article Now

Add this article to your cart for $25.00