- On May 20, 2021, the FDA issued the final guidance on Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation – Non-clinical Testing and Clinical Considerations.
- On July 29, 2021, the FDA hosted a webinar for stakeholders interested in learning about the final guidance.
The FDA’s Center for Devices and Radiological Health (CDRH) conducts research to support science-based and transparent decisions and minimize assumptions and subjectivity in the device review process. FDA scientists advance regulatory science by developing new tools, standards and approaches to assess the safety, efficacy, quality, and performance of medical devices.
FDA regulatory science for neurological devices includes research on:
- The development of more reliable neural interface devices.
- Identification of new systems-level biomarkers for neurological diseases.
- Comparisons of invasive and non-invasive neural interface devices to characterize both safety and efficacy over long periods of time.
- New methods of analysis and data visualization to extract as much useful information as possible from physiological recordings.
- Developing test methods for upper limb performance and cognitive load to evaluate upper limb prosthetics.
- Changes in neurophysiology, anatomy, behavior, and electrode material properties caused by cortical implants.
- Performance metrics to assess the long-term safety and performance of peripheral nerve interfaces.
- Electronic modeling techniques that can be used for magnetic resonance imaging (MRI) testing.
- Detection of brain injury.
- Applications of high intensity therapeutic ultrasound to diagnosing and treating brain injuries.
- Long-term performance of neural implants.