The Food and Drug Administration (FDA) will issue a guidance document on May 20, 2021, regarding non-clinical testing and clinical considerations regarding brain-computer interface (BCI) devices. Implanted BCI devices are neuroprostheses that interface with the patient's nervous system to restore lost motor and/or sensory capabilities for patients with paralysis or amputation. The guidance document is a leapfrog guidance, intended to share initial thoughts regarding emerging technologies early in product development, and is nonbinding.


The guidance document describes information that should be included in submission for an investigational device exemption (IDE). Along with detailed technical specifications, the FDA recommends that the applicant submit risk analysis detailing potential hazards of the device from the perspective of the user; description of the software and hardware supporting operation of the device, including information on cybersecurity aspects; and potential use-related hazards that could result from the user interface design.


The guidance document also includes comment on clinical study considerations. It states that implanted BCI devices are likely to be significant risk devices subject to all requirements of the IDE regulation. The guidance suggests design components which should be considered when developing the clinical study protocol, including implications relating to studying BCI devices in realistic home use environments that may require assessing caregiver safety and what training caregivers will require to assist the patient. The FDA recommends a long-term follow-up period of at least a year, due to the current lack of data on long-term effectiveness of implanted electrodes. Also, in addition to safety endpoints and effectiveness endpoints, patient input may be an important factor in evaluating the device. This would include patient preference information (such as whether the device is comfortable and user friendly) and patient-reported outcomes, such as pain reduction.

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