Final Guidance and Webinar: Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation

Learn about BCI device testing considerations

If your email program has trouble displaying this email, view as a webpage. FDA Issues Final Guidance on Implanted Brain-Computer Interface Devices for Patients with Paralysis or Amputation - Non-clinical Testing and Clinical Considerations 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. Non-clinical device testing can be used to demonstrate that potential risks have been mitigated prior to initiating a clinical study. 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. The U.S. Food and Drug Administration (FDA) issued this final guidance: Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation - Non-clinical Testing and Clinical Considerations, which is intended to facilitate the development of safe and effective products employing this emerging technology. Read the Guidance Questions? If you have questions about this final guidance, contact the Division of Industry and Consumer Education.

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