A researcher instructs a patient on how to move an artificial hand using a brain/computer interface implant.
The FDA today issued leapfrog guidance for nonclinical testing and study design related to implanted brain-computer interface (BCI) devices.
Leapfrog guidance allows the agency to share its initial thoughts on emerging technologies that are early in development but appear likely to be of importance to public health, according to a Federal Register notice. The guidance offered by the FDA today represents its initial thinking, as recommendations may change down the line.
The guidance covers considerations for Investigational Device Exemptions (IDEs) feasibility and pivotal clinical studies for implanted BCI devices in patients with paralysis or amputation. The space for such devices has progressed from neuroscience discoveries to the application of these discoveries in technology.
The FDA limited its recommendations to implanted BCI devices that interface with the nervous system to restore motor and/or sensory capabilities in patients with paralysis or amputation.
In March 2019, the agency issued leapfrog draft guidance that proposed that non-clinical device testing can be used to demonstrate that potential risks have been mitigated before beginning a clinical study.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.
You can read the latest FDA guidance on BCI devices here.
