Analysis on the Regulation and Application of United States Artificial Intelligence Medical Device
YAN Shu, XU Dongzi, OUYANG Zhaolian
Department of Strategic Intelligence Research on Medical Device and Drug, Chinese Academy of Medical Sciences and Peking
Union Medical College, Beijing 100020, China
Abstract：Artificial intelligence medical devices have developed rapidly in recent years, and the United States takes the lead in
product review and approval process as well as regulatory system construction around the world. The regulatory system and review
processes of artificial intelligence (AI) medical device already approved by food and drug administration (FDA) were analyzed as
well as product application. The study shows that United States is exploring the innovative management system, hoping to speed up
the launch of products and strengthen the supervision of through product lifecycle by using real world post-market data. Though the
United States is still in the early stage of the development of AI medical device, there are already several products authorized by FDA
being used to monitor, diagnose and detect diseases, including cancer, cardiovascular diseases, fracture and ophthalmic disease. De
Novo and substantial equivalence are frequently used as premarket pathways for AI products, various methods of performance testing
and clinical evaluation are used, review experience gradually accumulated.
严舒，徐东紫，欧阳昭连. 美国人工智能医疗器械监管与应用分析[J]. 中国医疗设备, 2021, 36(2): 117-122.
YAN Shu, XU Dongzi, OUYANG Zhaolian. Analysis on the Regulation and Application of United States Artificial Intelligence Medical Device. China Medical Devices, 2021, 36(2): 117-122.
