Research Progress on Real-World Data of US Food and Drug Administration
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.
medical devicesreal-world dataUS Food and Drug Administrationregulationsregulatory cases
万方数据
维普
