The U.S. Food and Drug Administration (FDA) has issued a new draft guidance to encourage development of a new generation of implantable brain-computer interface (BCI) devices, to help patients suffering from paralysis or missing limbs regain mobility.
FDA commissioner Scott Gottlieb said the draft guidance's release was prompted by a recent public workshop, which defined BCI devices as "neuroprostheses that interface with the central or peripheral nervous system to restore lost motor or sensory capabilities."
The FDA said the guidance suggests non-clinical device testing can be used to demonstrate mitigation of potential risks prior to clinical tests.
Said Gottlieb, "Proper design of clinical trials is essential to provide reasonable assurance of safety and effectiveness to support a regulatory submission to the FDA."
From U.S. Food and Drug Administration
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