Tagged as: Digital Health

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Planning For The End: Goodwin FDA attorneys Steve Tjoe and Susan Lee highlight key takeaways From FDA’s draft guidances proposing transition plans for medical devices marketed under EUAs or enforcement policies during the COVID-19 Public Health Emergency

During the COVID-19 public health emergency, the United States Food and Drug Administration (FDA) has issued hundreds of Emergency Use Authorizations (EUAs) and numerous enforcement policies to facilitate the availability of important medical devices. On December 23, 2021, FDA published two draft guidances setting forth the Agency’s proposed process for…

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