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  5. Webinar - Unique Device Identification: Convenience Kits Final Guidance - May 21, 2019 - 05/21/2019 - 05/21/2019
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Webcast

Event Title
Webinar - Unique Device Identification: Convenience Kits Final Guidance - May 21, 2019
May 21, 2019

Webinar - Unique Device Identification: Convenience Kits Final Guidance - May 21, 2019 - 05/21/2019 - 05/21/2019


Date:
May 21, 2019
Time:
May 21, 2019

On Tuesday, May 21, 2019, from 3:00 p.m.-4:30 p.m. EDT, the FDA will host a webinar to share information and answer questions regarding the implementation of the “Unique Device Identification: Convenience Kits” final guidance. Registration is not necessary.

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.