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Shuren: CDRH Writing Guidance To Explain What Should Happen To All Those EUA Tests, Devices

 
• By Shawn M. Schmitt

Jeff Shuren, director of the US FDA’s device center, says the agency is drafting a guidance document that will give industry recommendations on how it should handle products granted emergency use authorization during the COVID-19 public health emergency, once it’s over. The guidance will also address already-approved devices that were modified by their makers under enforcement discretion.

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The US Food and Drug Administration’s device center is writing a draft guidance document that will explain what should happen to the many products it granted emergency use authorization (EUA) during the COVID-19 public health emergency, once it’s over.

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