In a Cargo Systems Messaging Service (CSMS) message published on November 6, 2023, The Food and Drug Administration (FDA) reminded importers of the beginning of Phase 3 of the “Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency”. This is the final phase in FDA’s plan to bring List 1 devices that were issued Emergency Use Authorizations (EUA’s) into compliance with FDA enforcement policies.
Previously, List 1 medical devices that had EUA’s issued during the COVID-19 Public Health Emergency could be transmitted with the Intended Use Code (IUC) 940.000 for “Compassionate Use/Emergency Use Device." With the start of Phase 3, those List 1 devices should now be transmitted with an IUC of 081.001 for “Standard Import of a Device” and will be “expected to comply with all statutory and regulatory requirements applicable to their devices.”
Phase 3 of the Transition Plan begins on November 7, 2023.
CSMS #58306521 update on Phase 3 can be found here:
The original CSMS #56244578 that details the transition plan can be found here: