The U.S. Food and Drug Administration (FDA) recently released draft guidance to help spur development of Brain-Computer Interfaces (BCI) devices for patients with paralysis or amputation. A BCI is a computer-based system that acquires brain signals, analyzes them and translates them into commands that are relayed to an output device to carry out a desired action. For example, BCI could enable a person who cannot speak or type to communicate on a computer or tablet by thinking about making cursor movements and clicks. BCIs cannot not be used to force unwilling participants to produce a specific action; rather, they enable users to act by using brain signals rather than muscles.
The Emerging Sciences Working Group, a team of 15 FDA experts representing various specialties, has been charged with leveraging scientific expertise and resources to determine what applications hold the most promise. Their draft guidance includes recommendations for developers on what non-clinical testing and clinical study design could be used to develop BCI devices for patients with paralysis or amputation, including technical advice and recommendations for study designs to support safety and effectiveness of the devices.
The draft guidance is available here.