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  

Advances and future research prospects in regulatory policies for clinical trials of artificial intelligence medical devices

作　　者：梁浩 王顺 崔诚 宋玲 孙爱霖 李曼 乔杰[3] 宋纯理[3] 李海燕[3] 赵阳光 李海燕 张晨光 刘东阳 LIANG Hao;WANG Shun;CUI Cheng;SONG Ling;SUN Ailin;LI Man;QIAO Jie;SONG Chunli;LI Haiyan;ZHAO Yangguang;LI Haiyan;ZHANG Chenguang;LIU Dongyang(Drug Clinical Trial Center,Institute of Medical Innovation,Peking University Third Hospital,Beijing 100191,China;China Academy of Information and Communications Technology,Beijing 100191,China;Institute of Medical Innovation,Peking University Third Hospital,Beijing 100191,China;Center for Medical Device Evaluation,National Medical Products Administration,Beijing 100081,China)

机构地区：[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 [2]中国信息通信研究院,北京100191 [3]北京大学第三医院医学创新研究院,北京100191 [4]国家药品监督管理局医疗器械技术审评中心,北京100081

出　　处：《中国临床药理学与治疗学》2025年第3期427-431,共5页Chinese Journal of Clinical Pharmacology and Therapeutics

基　　金：人工智能医疗器械创新任务揭榜入围单位项目。

摘　　要：人工智能(artificial intelligence,AI)已成为引领未来的战略性技术,也是中国未来发展的关键引擎。在医疗器械的创新研发中,AI已经在智能辅助诊断、智能辅助治疗、智能监护与生命支持等方面提供了关键支持,机器学习赋能设备软件功能(machine learning-enabled device software functions,ML-DSFs)已成为许多医疗器械的重要组成部分。近期,美国食品药品监督管理局(Food and Drug Administration,FDA)发布了《针对人工智能/机器学习赋能设备软件功能的预设变更控制计划上市提交建议的指南草案》,希望提供一个前瞻性方法来促进机器学习医疗器械的发展,在保证设备的持续安全性和有效性前提下,支持ML-DSF通过修改来迭代更新。该指南代表了最新的监管方向,特别有助于提升AI产品临床试验质量与效率,因此撰写本文加以详细介绍和解读,以利于借鉴国际先进监管理念和经验,促进产业健康发展和国际影响力提升。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 assistance,intelligent monitoring,life support,et al.Machine 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an essential component of many medical devices.Recently,the United States Food and Drug Administration(FDA)released a draft guidance titled"Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning(AI/ML)-Enabled Device Software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 continuous safety and effectiveness of the devices.This guidance represents the latest in regulatory direction and is especially beneficial for enhancing the quality and efficiency of clinical trials for AI products.Therefore,we plan to provide a detailed introduction 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.

关 键 词：人工智能 医疗器械 机器学习赋能设备软件功能 指南 

分 类 号：R969[医药卫生—药理学]