The U.S. Food and Drug Administration has issued what the agency is describing as a “first-of-a-kind guidance” to help medical device manufacturers get through the review process for new devices.
The FDA is issuing the document, titled “Factors To Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications,” to address problems that have come up recently as a result of the agency’s approval process.
An FDA spokeswoman has been quoted as saying: “The devices center identified several ...
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