Webcast
Event Title
Webinar on Implanted BCI Devices for Patients with Paralysis or Amputation - Non-clinical Testing and Clinical Considerations Final Guidance
July 29, 2021
- Date:
- July 29, 2021
- Time:
-
11:00 AM - 12:30 PM ET
Tell us what you think about the webinar
Summary
On Thursday, July 29 at 11 am ET, the U.S. Food and Drug Administration (FDA), will host 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.
This webinar will
- Describe non-clinical testing recommendations associated with implanted BCI devices for patients with paralysis or amputation with industry and stakeholders.
- Discuss 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.
We encourage all interested stakeholders to join. Registration is not necessary.
Background
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.