2021-05-20 00:00 United States Policy & Regulation Regulatory Approval Translated from EN

FDA Issues Final Guidance on Implanted BCIs

Summary The FDA issued final guidance in 2021 on implanted brain-computer interface (BCI) devices for patients with paralysis or amputation, covering nonclinical testing and clinical study design.

Why it matters The guidance is the regulatory cornerstone of implanted BCI clinical translation in the United States, the framework within which investigational device exemption (IDE) trial designs from Neuralink, Synchron and other developers operate.

BCIwiki (bciwiki.com) — The Food and Drug Administration under the US Department of Health and Human Services (Health and Human Services Department, Food and Drug Administration) announced in the Federal Register on May 20, 2021 (document 2021-10622) the availability of the final guidance ‘Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation — Non-Clinical Testing and Clinical Considerations’, addressed to industry and FDA staff.

The guidance defines implanted brain-computer interface devices as neuroprostheses that interface with the central or peripheral nervous system to restore lost motor and/or sensory capabilities in patients with paralysis or amputation. It provides recommendations for nonclinical testing of such devices, along with study design considerations for feasibility and pivotal clinical studies conducted under investigational device exemptions.

Compiled by BCIwiki from public sources

Sources · 1

federalregister.gov 2021-05-20

U.S. Food and Drug Administration Clinical Translation Invasive BCI United States

U.S. Food and Drug Administration timeline

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