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February 25, 2019

FDA issues draft guidance for brain-computer interface devices

The US Food and Drug Administration (FDA) has issued draft guidance to drive the development of brain-computer interface (BCI) devices, a new generation of implants that could provide users with direct control.

The US Food and Drug Administration (FDA) has issued draft guidance to drive the development of brain-computer interface (BCI) devices, a new generation of implants that could provide users with direct control.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

“FDA commissioner Scott Gottlieb referred to the draft guidance as a ‘leap-frog’ guidance to help bridge current technology with future innovations.”

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.

The agency said that an outcome of the workshop was the initiation of the draft guidance, which will be open to public comment as it is finalised.

This guidance is intended to help developers, as well as maintain necessary protections for patients.

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FDA commissioner Scott Gottlieb referred to the draft guidance as a ‘leap-frog’ guidance to help bridge current technology with future innovations.

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 Today, we’re issuing draft guidance to help spur development of BCI devices for patients with paralysis or amputation, including our nation’s veterans.”

The draft guidance outlines recommendations for developers on non-clinical testing and clinical study design that could be leveraged to create BCI devices for patients with paralysis or amputation.

Specifically, the FDA is offering detailed technical advice and recommendations for study designs to support safety and effectiveness.

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

Additional reporting by Charlotte Edwards. 

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