Brain-Computer Interface Devices for Patients with Paralysis and Amputation: A Meeting Report.
K Bowsher, EF Civillico, J Coburn, J Collinger, JL Contreras-Vidal, T Denison, J Donoghue, J French, N Getzoff, LR Hochberg, M Hoffmann, J Judy, N Kleitman, G Knaack, V Krauthamer, K Ludwig, M Moynahan, JJ Pancrazio, PH Peckham, C Pena, V Pinto, T Ryan, D Saha, H Scharen, S Shermer, K Skodacek, P Takmakov, D Tyler, S Vasudevan, K Wachrathit, D Weber, CG Welle, M Ye
The Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) believes it is important to help stakeholders (eg, 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 …
Journal of neural engineering