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COVID-19: Regulatory Considerations for Medical Device Companies

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Medical device manufacturers are facing numerous novel legal, regulatory, and commercial issues as a result of the evolving COVID-19 public health emergency. This slide presentation addresses key regulatory considerations for medical device companies seeking to supply products that are in critical need, including the Emergency Use Authorization pathway and other recently announced FDA policies as well as considerations in the EU. We also explain how the public health emergency impacts ongoing premarket and postmarket activities of FDA and device manufacturers.

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