脑机接口的发展和监管挑战

Development and Regulatory Challenges of Brain-Computer Interface

植入式脑机接口目前正处于技术爆发阶段,该技术通过在大脑与外部设备之间建立通信,常用于言语康复、运动康复、神经康复和神经系统疾病治疗。文章就国内外脑机接口研究进展进行概述,介绍了美国食品药品管理局发布的关于植入式脑机接口设备指导原则的相关内容,也介绍了我国脑机接口设备的政策引导与技术监管的概况,同时对植入式脑机接口设备监管可能面临的挑战提出了相关思考,以期为该类产品的上市前监管提供思路。

The implanted brain-computer interface(BCI)is currently in the stage of technological explosion.This technology establishes communication between the brain and external devices for speech rehabilitation,motor rehabilitation,neurological rehabilitation and treating neurological diseases.This article summarizes the research progress of BCI at home and abroad,introduces the guidance document of implanted BCI devices issued by the Food and Drug Administration(FDA),as well as the overview of policy and technical regulation of BCI equipment in China.At the same time,it proposes some author’s thoughts on the challenges that may encounter by regulatory authorities regarding such products.It aims to provide ideas for pre-market regulatory of these products.