FDA releases brain-computer interface draft guidance

The FDA today released draft guidance for brain-computer interface devices, an emerging novel technology that allows users direct control of devices.

Brain-computer interface devices, which are currently all experimental, allow direct control of devices and are often used to control limb prostheses. The experimental systems have the potential to significantly aid individuals with severe disabilities and increase their level of interaction with the environment, the FDA said.

The federal watchdog said it recently held a public workshop focused on BCI devices which defined them as “neuroprostheses that interface with the central or peripheral nervous system to restore lost motor or sensory capabilities.”

The FDA said that a result of the workshop was the initiation of the draft guidance, which will be open to public comment as it is finalized.

FDA head Dr. Scott Gottlieb said that the draft guidance is considered a “leap-frog” guidance intended to help bridge current technology with future innovations.

The newly released guidance provides 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.

The FDA said that the guidance proposes that non-clinical device testing can be used to demonstrate mitigation of potential risks prior to clinical testing.

“Proper design of clinical trials is essential to provide reasonable assurance of safety and effectiveness to support a regulatory submission to the FDA,” Gottlieb wrote in the release.

The FDA said that it has also developed the Emerging Sciences Working Group, a team of 15 experts charged with conducting long-range horizon scanning and reporting back on emerging issues and new scientific advances.

In late 2017, researchers at Battelle  touted that the 1st user of its experimental NeuroLife system, a BCI system designed to restore upper body mobility control to paralyzed patients through mental control, has shown improved control smoothness and accuracy with the system.

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