Bowsher K, Civillico E F, Coburn J, Collinger J, Contreras-Vidal J L, Denison T, Donoghue J, French J, Getzoff N, Hochberg L R, Hoffmann M, Judy J, Kleitman N, Knaack G, Krauthamer V, Ludwig K, Moynahan M, Pancrazio J J, Peckham P H, Pena C, Pinto V, Ryan T, Saha D, Scharen H, Shermer S, Skodacek K, Takmakov P, Tyler D, Vasudevan S, Wachrathit K, Weber D, Welle C G, Ye M
US FDA, Center for Devices and Radiological Health, Office of Device Evaluation, Silver Spring, MD, USA.
J Neural Eng. 2016 Apr;13(2):023001. doi: 10.1088/1741-2560/13/2/023001. Epub 2016 Feb 29.
The Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) believes it is important to help stakeholders (e.g., manufacturers, health-care professionals, patients, patient advocates, academia, and other government agencies) navigate the regulatory landscape for medical devices. For innovative devices involving brain-computer interfaces, this is particularly important.
Towards this goal, on 21 November, 2014, CDRH held an open public workshop on its White Oak, MD campus with the aim of fostering an open discussion on the scientific and clinical considerations associated with the development of brain-computer interface (BCI) devices, defined for the purposes of this workshop as neuroprostheses that interface with the central or peripheral nervous system to restore lost motor or sensory capabilities.
This paper summarizes the presentations and discussions from that workshop.
CDRH plans to use this information to develop regulatory considerations that will promote innovation while maintaining appropriate patient protections. FDA plans to build on advances in regulatory science and input provided in this workshop to develop guidance that provides recommendations for premarket submissions for BCI devices. These proceedings will be a resource for the BCI community during the development of medical devices for consumers.
美国食品药品监督管理局（FDA）的器械与放射健康中心（CDRH）认为，帮助利益相关者（如制造商、医疗保健专业人员、患者、患者权益倡导者、学术界以及其他政府机构）了解医疗器械的监管环境非常重要。对于涉及脑机接口的创新器械而言，这一点尤为重要。
为实现这一目标，2014年11月21日，CDRH在其位于马里兰州怀特奥克的园区举办了一次公开研讨会，旨在就与脑机接口（BCI）器械开发相关的科学和临床考量展开公开讨论。本次研讨会将BCI器械定义为与中枢或外周神经系统对接以恢复丧失的运动或感觉功能的神经假体。
本文总结了该研讨会的报告和讨论内容。
CDRH计划利用这些信息制定监管考量措施，以促进创新的同时确保对患者的适当保护。FDA计划基于监管科学的进展以及本次研讨会提供的意见，制定相关指南，为BCI器械的上市前申报提供建议。在为消费者开发医疗器械的过程中，这些会议记录将成为BCI领域的一项资源。
