Assessment of the Benefit Risk tradeoff for diagnostic devices
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*Norberto Pantoja-Galicia, FDA  Gene Pennello, FDA 

Keywords: Diagnostic Device, Benefit-Risk, tradeoff

In the biostatistical literature, emphasis is being placed on risk-benefit, decision analysis, and sensitivity analysis to assess medical products. Consideration of probable benefits and risks is an important component in the determination that there are reasonable assurances of safety and effectiveness of a medical device. The consequences of a particular clinical decision informed by the diagnostic device should be taken into consideration when evaluating such device. We will discuss examples and analyses that may aid in the assessment of the benefit-risk tradeoff in Diagnostic Devices.