FDA issues ‘leap-frog’ guidance on brain/computer interfaces

This article was originally published here

A researcher instructs a patient on how to move an artificial hand using a brain/computer interface device.

FDA has issued draft guidance for developers of devices to help amputees and people with paralysis regain mobility or their sense of touch.

FDA defines brain/computer interface (BCI) devices as neuroprostheses that interface with the central or peripheral nervous system to restore lost motor or sensory capabilities. The guidance proposes that non-clinical device testing can be used to demonstrate that potential risks have been mitigated before beginning a clinical study. It also provides detailed recommendations on preparing to submit an application for an investigational device exemption.

Get the full story on our sister site, Medical Design and Outsourcing.


The post FDA issues ‘leap-frog’ guidance on brain/computer interfaces appeared first on MassDevice.

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