FDA人工智能医疗器械软件变更的监管思路分析

FDA’s Supervision Thoughts on Modification of Artificial Intelligence Medical Device Software

人工智能技术为医疗器械创新带来新的契机,人工智能医疗器械软件与传统医疗器械软件相比较呈现出一些新的特点。文章对美国国家食品药品监督管理局(FDA)提出的一项旨在促进人工智能医疗器械自我学习、迭代更新的变更监管框架提议进行介绍。该提议允许企业在软件全生命周期管理条件下,在注册时提交一系列规范文件,为预期变更提前制定计划。

Artificial intelligence technology brings new opportunities for medical device innovation.Compared with traditional medical device software,artificial intelligence medical device software presents some new features.This article introduces a framework proposed by the US Food and Drug Administration(FDA).This framework allows manufactures to submit relevant regulatory documents at the time of initial registration under the requirement of total product lifecycle regulatory to develop a plan for expected modifications in advance.