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  • Véronique Li, Senior Medical Device Regulation Expert

    • FDA Issues UDI Guidance for Class I and Unclassified DevicesJanuary 30th, 2018

      The final Unique Device Identifier (UDI) Rule was published on September 24, 2013. The last phases of implementation related primarily to Class I and Unclassified devices.  Due to complex issues identified during implementation of the UDI Rule for Class II and III devices, FDA is …