Using Decision Analysis to Regulate Medical Devices
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*Telba Irony, CDRH, FDA 

Keywords: Benefit-risk, decision analysis, medical device, post-marketing

The Center for Devices and Radiological Health at the FDA is starting to use quantitative decision analysis in regulating medical devices across the total product life cycle. The idea is to analyze certain situations in which policy makers need to make a decision and to frame the issue as a decision analysis problem. Possible decisions involve both pre and post market issues. In this talk we will describe the ideas being explored and present case studied in which decision analysis has been used in the post-market setting.