Draft Guidance for Industry and Food and Drug Administration Staff; Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Review; Availability

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The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled "Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Review." The recommendations in this guidance are intended to provide greater clarity on FDA's decisionmaking process with regard to benefit-risk determinations in the premarket review of medical devices. This draft guidance is not final nor is it in effect at this time.