Guidance for Industry and Food and Drug Administration Staff; Factors To Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and de Novo Classifications; Availability

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The Food and Drug Administration (FDA) is announcing the availability of the guidance document entitled "Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications." This guidance is intended to provide greater clarity on FDA's decisionmaking process with regard to benefit-risk determinations in the premarket review of medical devices in the premarket approval and de novo pathways.