Draft guidance for brain-computer interface devices issued by FDA

The emerging novel technology, brain-computer interface devices, are currently experimental systems, often used to control limb prostheses, and could dramatically help patients with severe disabilities and increase their level of interaction with the environment. Now the FDA has issued draft guidance for such devices which Dr. Scott Gottlieb, head of the FDA, says is a “leap-frog” guidance intended to help bridge current technology with future innovations. He said: “Proper design of clinical trials is essential to provide reasonable assurance of safety and effectiveness to support a regulatory submission to the FDA.”
The new draft guidance contains proposed recommendations for developers on what non-clinical testing and clinics study design could be used for developing BCI devices for patients with paralysis or amputations, and includes detailed technical advice and study design recommendations. Its recommendation is that non-clinical device testing can be used to demonstrate mitigation of potential risks prior to clinical testing.