FDA Transition Plan for Medical Devices Marketed Under EUA or an Enforcement Policy During the COVID-19 Pandemic
Published May 12, 2023
Summary
CBP relays FDA's transition plan and phased timeline for medical devices previously marketed under EUAs or COVID-19 enforcement policies, detailing the specific Intended Use Codes and Affirmation of Compliance data that importers must transmit in ACE at each phase. The notice outlines implementation dates in 2023 for shifting from EUA/enforcement-policy entry codes to standard device import codes.
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