Using Quantitative Decision Analysis in the Regulation of Medical Devices
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*Telba Irony, Center for Devices and Radiological Health - FDA 

Keywords: quantitative decision analysis, medical devices, regulatory setting

The Center for Devices and Radiological Health at the FDA has been using quantitative decision analysis in the regulation of medical devices for a few years. In this presentation we will describe the Center efforts in utilizing this powerful tool to assist regulatory decision making. In particular, we will provide examples of the use of Quantitative Decision Analysis to make important regulatory decisions.