Unique Device Identification: Convenience Kits Final Guidance
U.S Food & Drug Administration
The FDA hosted this webinar to announce its implementation of the “Unique Device Identification: Convenience Kits” final guidance.
This final guidance describes FDA’s definition of “convenience kit” for purposes of applying unique device identifier (UDI) requirements. The webinar will clarify the FDA’s policy on UDI considerations for “medical procedure kits”. The exception for devices within a convenience kit is designed to maintain adequate identification of devices through distribution and use.
Slides and a transcript are also available.
Webinar Type: Recorded