Keywords: real world evidence, medical devices, statistics, FDA, CDRH
Electronic health records and mobile phone app have been widely accepted by providers and patients as useful tools for clinical management. Novel sources of data have become more readily available every day. Major stakeholders of the medical product ecosystem are interested to explore how to utilize these data to reduce the costs of clinical trials. Therefore, methodology of evaluating the quality of these data and translating them into valid scientific evidence to inform regulatory considerations have become a very vibrant research area. In this presentation, I will describe how real world evidence has informed medical device regulatory decision making and discuss the barriers and opportunities from statistical and regulatory perspectives.