The Decision Analysis Initiative at the Center for Devices and Radiological Health
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*Telba Irony, Center for Devices and Radiological Health, FDA 

Keywords: Decision Analysis, Benefit-Risk, Medical Device

In this presentation we will show how Decision Analysis is being used at CDRH. We will talk about a project that used Decision Analysis to regulate devices to treat depression. That project gave origin to the guidance document entitled “Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications,” that was released by CDRH and CBER in March, 2012. Among these factors, Patient Tolerance for Risk and Perspective on Benefit should also be considered. Following up on that idea, we will also discuss a pilot survey on Patient Risk Tolerance that is being sponsored by CDRH.