Incorporating Patient Preferences into Regulatory Decision Making
*Telba Irony, FDA 


On March 2012, the Center for Devices and Radiological Health (CDRH) at the FDA issued a guidance document listing the factors considered when the Center makes Benefit – Risk determinations for approval of medical devices. A ground-breaking factor described in the guidance is “Patient Tolerance for Risk and Perspective on Benefit”. The Center recognizes that considering patient preferences is essential because only patients live with their medical conditions and consequences of the choices they make for their own care. Until now, this factor has not been formally considered in the regulatory setting. To explore the use of patient preference evidence into regulatory benefit-risk determinations, CDRH sponsored a survey to elicit obese patients’ preferences in choosing weight-loss devices. In this presentation, we will describe the weight-loss device survey and present the survey results, which have been used to develop a powerful decision-aid tool for regulatory reviewers. The tool provides estimates of patients’ benefit-risk tradeoff preferences and also stratifies patients according to their risk-tolerance. We will conclude the presentation by sharing experiences in using patient preferences in regulatory process and talking about the draft guidance document on patient preference information - submission, review and inclusion in device labeling.