- July 29, 2021
On July 29, 2021 the U.S. Food and Drug Administration (FDA), hosted a webinar for stakeholders interested in learning about the final guidance on Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation - Non-clinical Testing and Clinical Considerations.
During this webinar the FDA:
- Described non-clinical testing recommendations associated with implanted BCI devices for patients with paralysis or amputation with industry and stakeholders; and
- Discussed recommended clinical trial designs to provide a reasonable assurance of safety and effectiveness necessary to support a regulatory submission, and translation of BCI devices from concept to assisting device users.
Implanted brain-computer interface (BCI) devices have the potential to bring benefit to people with severe disabilities by restoring lost motor and sensory capabilities in patients with paralysis or amputation. The field of implanted BCI devices is progressing rapidly. Proper design of clinical trials is essential to provide a reasonable assurance of safety and effectiveness necessary to support a regulatory submission, and translation of BCI devices from concept to assisting device users. This webinar is intended to share non-clinical testing and clinical study design recommendations associated with implanted BCI devices.
The presentation, printable slides, and transcript are available at CDRH Learn under "Specialty Technical Topics", sub-section "Neurological Devices."