Abstract: In recent years, with the development of big data application technology, the real-world data and the corresponding generated real-world evidence have attracted the attention of the global healthcare regulatory authorities around the world. Regulators recognize that real-world research with specific purposes, conducted using real-world data can provide important evidence for regulatory decisions. 90 instances of publicly releasing the application of real-world evidence to support Food and Drug Administration regulatory decisions are explored,the positioning and value of real-world evidence in Food and Drug Administration regulatory decision are summarized and analyzed , and provides reference for using real-world data and real-world evidence to promote medical devices whole cycle regulatory in China.