FDA releases draft guidance for brain-computer interface devices

27 February 2019

The FDA has just issued draft guidance to drive the development of brain-computer interface (BCI) devices, a new generation of implants that could provide users with direct control.

BCI devices are often used to regulate limb prosthesis. These can significantly improve both mobility and independence for patients. The FDA added that the devices also provide the potential to help people living with severe disabilities by improving their ability to interact with their environment.

FDA commissioner Scott Gottlieb referred to the document as a ‘leap-frog’ guidance to help bridge current technology with future innovations.

This advice comes after the FDA Centre for Devices and Radiological Health held a workshop focused on BCI devices. The guidance will be open to public comment once it has been finalised.

FDA commissioner Scott Gottlieb referred to the draft guidance as a ‘leap-frog’ guidance to help bridge current technology with future innovations.

“This is a critical area of development for the millions of people who suffer from conditions that inhibit their mobility,” said Gottlieb. “Today, we’re issuing draft guidance to help spur development of BCI devices for patients with paralysis or amputation, including our nation’s veterans.”

The document outlines recommendations for developers on both non-clinical and clinical study design that could be leveraged to create BCI devices for patients with paralysis or amputation. These aim to ensure both safety and effectiveness of research outputs.

“The FDA is also committed to collaborating with stakeholders, including product developers, across the healthcare ecosystem on specific areas that we know are advancing and ripe for disruption,” sad Gottlieb.  

Technological developments for prosthetic limb patients are continuing to advance in other areas too. Only last week, a team of researchers revealed that they had developed a bionic hand to help amputees regain an instant and accurate sense of the position of limbs during and after movement.



Privacy Policy
We have updated our privacy policy. In the latest update it explains what cookies are and how we use them on our site. To learn more about cookies and their benefits, please view our privacy policy. Please be aware that parts of this site will not function correctly if you disable cookies. By continuing to use this site, you consent to our use of cookies in accordance with our privacy policy unless you have disabled them.