In 2016,the US Food and Drug Administration(FDA)first proposed that real-world data(RWD)could be used to support regulatory decision-making.Since then,the FDA has gradually developed a regulatory framework that emphasizes the importance of RWD in the pre-market approval and post-market supervision of medical devices.This framework also helps applicants understand and adopt RWD for registration and reporting purposes.Based on the FDA's experience and case studies of accepting RWD in medical device registration reviews,this article summarizes the FDA's regulatory framework for RWD and its data development.It also analyzes case studies in which RWD supported FDA regulatory decision-making,aiming to provide a reference for the application of RWD in China's medical device regulatory decisions.
关键词
医疗器械/真实世界数据/美国食品药品监督管理局/法规/监管案例
Key words
medical devices/real-world data/US Food and Drug Administration/regulations/regulatory cases
维普
万方数据