Advances and future research prospects in regulatory policies for clin-ical trials of artificial intelligence medical devices
10.12092/j.issn.1009-2501.2025.03.017
- VernacularTitle:人工智能医疗器械临床试验监管政策进展及未来研究展望
- Author:
Hao LIANG
1
;
Shun WANG
;
Cheng CUI
;
Ling SONG
;
Ailin SUN
;
Man LI
;
Jie QIAO
;
Chun-li SONG
;
Haiyan LI
;
Yangguang ZHAO
;
Haiyan LI
;
Chenguang ZHANG
;
Dongyang LIU
Author Information
1. 北京大学第三医院医学创新研究院药物临床试验机构,北京 100191
- Publication Type:Journal Article
- Keywords:
artificial intelligence;
medical device;
machine learning-enabled device software func-tions;
guidance
- From:
Chinese Journal of Clinical Pharmacology and Therapeutics
2025;30(3):427-431
- CountryChina
- Language:Chinese
-
Abstract:
Artificial intelligence(AI)has emerged as a cutting-edge technology leading the future and is a key engine for China's development.In the innovation and research of medical devices,AI has provided critical support in the areas of intelligent diagnostic assistance,intelligent therapeutic assis-tance,intelligent monitoring,life support,et al.Ma-chine learning-enabled device software functions(ML-DSFs)have become an essential component of many medical devices.Recently,the United States Food and Drug Administration(FDA)released a draft guidance titled"Marketing Submission Rec-ommendations for a Predetermined Change Con-trol Plan for Artificial Intelligence/Machine Learn-ing(AI/ML)-Enabled Device Software Functions(Draft)."that aimed to provide a forward-looking approach to foster the development of ML medical devices.By supporting iterative updates through modifications,this approach ensures the continu-ous safety and effectiveness of the devices.This guidance represents the latest in regulatory direc-tion and is especially beneficial for enhancing the quality and efficiency of clinical trials for AI prod-ucts.Therefore,we plan to provide a detailed intro-duction and interpretation of the guidance,with the aim of learning from international advanced regulatory concepts and experiences to promote the development of ML-DSFs with more profound international influence.
