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.
维普
万方数据
