- May 21, 2019
03:00 PM - 04:30 PM EDT
On Tuesday, May 21, 2019, from 3:00 p.m.-4:30 p.m. EDT, the FDA hosted a webinar to share information and answer questions regarding the implementation of the “Unique Device Identification: Convenience Kits” final guidance.
This final guidance, “Unique Device Identification: Convenience Kits,” describes FDA’s interpretation of the definition of “convenience kit” for purposes of applying unique device identifier (UDI) requirements only. The FDA is issuing this guidance to, among other things:
- Clarify the FDA’s policy related to UDI considerations for “medical procedure kits”
- Help ensure that the exception for UDI labeling of devices within the immediate container of a convenience kit is applied in a way that provides adequate identification of devices through distribution and use.