FDA issues draft guidance for brain-computer interface devices

BCI devices are often used to regulate limb prosthesis. The direct control feature of these implants is expected to enable significantly more mobility and independence for patients.

The regulatory agency added that the devices possess the potential to help people living with severe disabilities by improving their ability to interact with their environment.

Recently, FDA Center for Devices and Radiological Health held a workshop focused on BCI devices, which were defined as brain implants that communicate with a patient’s nerves and muscles in order to help them gain mobility or a sense of touch.