The FDA released a guidance document on the non-clinical testing and clinical considerations of ‘Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation’. The document can be downloaded from the FDA website.

One point of particular interest comes from the software section, where the FDA states that “We generally consider the software for implanted BCI devices to present a “major” level of concern.” If this is not the case, the manufacturer should provide scientific justification for their rationale. It then goes on to point to several relevant standards that they recommend to be followed when putting together a submission.