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FDA Finalizes Framework for Transitioning from COVID-Related Medical Devices EUA/Enforcement Discretion to Permanent Marketing Authorization | Morgan Lewis

The US Food and Drug Administration has finalized the framework for transitioning medical devices previously granted emergency use authorization or subject to particular enforcement. ....

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FDA Issues Final Transition Guidances For COVID-19 Devices - Healthcare

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). ....

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Be Prepared: FDA Signals Transition Countdown for Medical Devices Marketed Under COVID-Era Enforcement Policies, EUAs | Wiley Rein LLP

On October 17, 2022, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) released the list of guidance documents proposed for publication in. ....

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