ABSTRACT
54In March 2012, the Center for Devices and Radiological Health at the Food and Drug Administration issued a guidance document describing the factors to be considered when the Center makes benefit–risk determinations for medical device premarket reviews. Decision analysis provided the foundations and motivation for this guidance to industry and staff who have to weigh these factors when making benefit–risk determinations for medical device approval. In this chapter, we will discuss these factors and briefly provide examples to illustrate how to weigh these factors in order to reach regulatory decisions for approval of medical devices. A groundbreaking factor described 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 obtain quantitative evidence on how patients weigh benefits against risks and how this evidence could be used in the regulatory setting.
