04
Jan
On December 22, 2021, the U.S. Food and Drug Administration (FDA) issued two draft guidance documents for the transition plans for medical devices commercialized pursuant to either Emergency Use Authorization (EUA) or the FDA’s Enforcement Policies during the Coronavirus Disease 2019 (COVID-19) public health emergency (COVID-19 PHE). The draft guidance for EUAs can be located here, and the draft guidance for devices commercialized under the FDA’s COVID-19 Enforcement Policies can be located here.
This alert provides an overview of the draft guidance(s).
Overview
The...