Uncertainty remains: FDA releases new benefit-risk decision tree for medical device PMAs and De Novos in concert with final uncertainty guidance

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On 30 August 2019 the U.S. Food and Drug Administration (FDA or the agency) issued a final guidance document entitled "Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions" (uncertainty guidance) in tandem with an updated version of the final guidance "Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications" originally released in August 2016 (benefit-risk guidance).

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