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Activity Number: 492
Type: Topic Contributed
Date/Time: Wednesday, August 6, 2014 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #311440 View Presentation
Title: Using Decision Analysis to Regulate Medical Devices
Author(s): Xuefeng Li*+ and Telba Z. Irony and Martin Ho
Companies: FDA and Center for Devices and Radiological Health and FDA
Keywords: Decision analysis ; Medical Devices ; patient preference ; Regulatory
Abstract:

The Center for Devices and Radiological Health at the FDA has been pioneering the use of decision analysis in the regulatory setting. In this presentation we will describe the Center efforts in utilizing this powerful tool to assist regulatory decision making. First, we will show how decision analysis was used by the agency in order to issue a Public Health Notification to advise physicians on the optimal time to remove Inferior Vena Cava filters from patients who need them temporarily. Next, we will explain how decision analysis was the driving force in the elaboration of the guidance to industry on the factors to be considered by FDA staff when benefit - risk determinations are made on the approval of medical devices. A ground-breaking factor listed in the guidance is "patient tolerance for risk and perspective on benefit". Until now, this factor has not been formally considered in the regulatory setting. Through an example, we will demonstrate how to elicit quantitative evidence on how patients weigh benefits against risks and how this evidence is being used in the regulatory setting.


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