The United States (U.S.) Food and Drug Administration (FDA) ensures that patients in the U.S. have access to safe and effective medical devices. The Division of Neurological and Physical Medicine Devices reviews medical devices that interface with the nervous system. This presentation will assist attendees in how to navigate the FDA’s regulatory landscape to successfully move medical devices to patients.
Agency Overview and Organization
Neurological Medical Device Review and Oversight
Clinical Overview and Perspectives
Broader Engagement and Best Practices for FDA Engagement
Mohamad Bydon, Robert Heary, Christopher Loftus, Carlos Pena