Analysis of Brain-Computer Interface Technology in the Medical Field and the Regulation of the US FDA.
10.12455/j.issn.1671-7104.240187
- Author:
Jiaying GUO
1
;
Jieying YANG
1
;
Yaohua LI
1
Author Information
1. Yangtze River Delta Center for Medical Device Evaluation and Inspection of NMPA, Shanghai,
- Publication Type:Journal Article
- Keywords:
American regulation;
brain-computer interface;
medical devices;
policies and regulations
- MeSH:
Brain-Computer Interfaces;
United States;
United States Food and Drug Administration;
Humans;
Electroencephalography
- From:
Chinese Journal of Medical Instrumentation
2025;49(1):96-102
- CountryChina
- Language:Chinese
-
Abstract:
Brain-computer interface (BCI) technology is an innovative and cutting-edge medical advancement that enables direct interaction between the brain and external devices, facilitating the reconstruction of daily functions for patients or serving as a method for neuro-regulation therapy. Although this technology offers a broad range of clinical applications, there are problems as potential risks, individual variations, and the need for long-term monitoring of its effects during utilization. Consequently, the comprehensive evaluation of its safety and effectiveness poses a considerable challenge for regulatory agencies. This study provides a concise introduction to the development history and various types of BCI technology, followed by a summary of the regulatory situation for different types of BCI medical devices in the United States. Furthermore, the regulatory requirements imposed by the US FDA on this product category are analyzed. Finally, the article concludes by presenting a summary and future perspective on the current development of BCI technology, with the aim of offering beneficial insights and guidance for the regulation of BCI medical devices.
