MoFo Life Sciences Blog
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This week, the U.S. Food & Drug Administration (FDA) issued two much anticipated guidances, each outlining how COVID-19 devices will be treated after the expiration of the COVID-19 public health emergency (PHE) declaration or termination of the COVID-19 Emergency Use Authorization (EUA) declarations: 1) Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (the “Enforcement Policy Transition Guidance”) and 2) Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19) (the “EUA Transition Guidance”), both dated March 27, 2023. These final guidance documents finalize the corresponding draft guidances issued on December 23, 2021, and both set out a 180-day transition period.
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