CSMS 58306521PGAprocedural

FDA Transition for Medical Devices Marketed Under EUA or an Enforcement Policy During the COVID-19 Pandemic

Published Nov 6, 2023

Summary

CBP relays FDA guidance on the phased transition for medical devices previously marketed under COVID-19 enforcement policies or EUAs, detailing which Intended Use Codes and Affirmation of Compliance information filers should transmit at entry as Phase 3 begins November 7, 2023.

Summary is machine-generated at the linking layer for discovery only. Refer to the source bulletin for authoritative guidance.

CSMS 58306521 · full bulletin