FDA has issued draft guidance for developers of devices to help amputees and people with paralysis regain mobility or their sense of touch.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