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FDA Announces Proposed Transition Plans for Devices Distributed under EUAs or COVID-19 Enforcement Policies

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  • FDA Announces Proposed Transition Plans for Devices Distributed under EUAs or COVID-19 Enforcement Policies

On December 23, 2021, FDA published two draft guidances outlining transition plans for devices distributed during the COVID-19 public health emergency pursuant to (1) emergency use authorizations (EUAs) or (2) an enforcement policy. The draft guidances describe FDA’s proposed approach to transitioning back to “normal operations” following the end of emergency declarations, at which time the Agency will require traditional marketing authorizations and enforce regulatory requirements for medical devices.

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