On May 12, 2023, in Cargo Systems Messaging Service (CSMS) #56244578, the U.S. Food and Drug Administration (FDA) announced the publication of guidance documents outlining the transition plan for medical devices under Emergency Use Authorizations (EUA) or under Enforcement Policies issued during the COVID-19 public health emergency. According to the CSMS, the guidance documents “will help prepare manufacturers and other stakeholders for the transition to normal operations and foster compliance with applicable regulatory requirements when EUAs and COVID-19-related enforcement policies are no longer in effect.
CSMS #56244578 can be found here:
https://content.govdelivery.com/bulletins/gd/USDHSCBP-35a3962?wgt_ref=USDHSCBP_WIDGET_2
The transition plan for products under EUAs can be found here:
https://www.fda.gov/media/155039/download
The transition plan for products under Enforcement Policies can be found here:
