FDA Resources for Device Development from the 2022 NeuroAbilities Virtual Symposium

Panel Session Resources Shared by the U.S. Food & Drug Administration (FDA) on March 31, 2022

For a complete recording of this session with captions and sign interpretation, please visit our YouTube Channel.

Neuro-specific:

  • Overview on Neurological Devices by the FDA

  • FDA Perspectives on the Regulation of Neuromodulation Devices (article)

  • Webinar on Implanted BCI Devices for Patients with Paralysis or Amputation - Non-clinical Testing and Clinical Considerations Final Guidance

  • Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation - Non-clinical Testing and Clinical Considerations (download)

  • FDA Regulation of Neurological and Physical Medicine Devices: Access to Safe and Effective Neurotechnologies for All Americans (article)

Other Resources: