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.
The US Food and Drug Administration’s device center is writing a draft guidance document that will explain what should happen to the many products it granted emergency use authorization (EUA) during the COVID-19 public health emergency,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.
The eventual guidance will also address already-approved devices that were modified by their manufacturers under enforcement discretion for the purposes...
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