FDA Posts Draft Guidance on Implanted Brain-Computer Interface Devices

FDA Posts Draft Guidance on Implanted Brain-Computer Interface Devices

Today, the U.S. Food and Drug Administration (FDA) issued the draft guidance, “Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation - Non-clinical Testing and Clinical Considerations.”

Facts About the Guidance The draft guidance provides the FDA’s recommendations for submitting Q-Submissions and Investigational Device Exemptions (IDEs) for implanted BCI devices designed to treat patients with paralysis or amputation. In this guidance, implanted BCI devices are neuroprostheses that interface (communicate) with the central or peripheral nervous system to restore physical mobility or sensory capabilities in patients with paralysis or amputation. This is a “leapfrog” guidance, meaning the guidance is intended to provide the FDA’s initial thoughts on an emerging health technology, therefore, the FDA’s recommendations may change as more information becomes available. Information about Submitting Comments to the FDA The FDA is accepting comments and suggestions regarding this draft guidance atwww.regulations.gov using Federal Register notice number: FDA-2014-N-1130, or by clicking the button below. Please submit comments or suggestions for consideration by April 26, 2019.

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Questions? If you have questions about this draft guidance, contact the Division of Industry and Consumer Education.