Tuesday, April 28
2:00 pm - 4:00 pm
The FDA: Investigational Device Exemptions, Regulatory Process and Moving Medical Devices to Patients
Director(s): William C. Welch, MD, FAANS
Faculty: Catherine Jeakle Hill; Joshua M. Rosenow, MD, FAANS
This session focuses on navigating the FDA regulatory landscape for medical devices. Faculty are professionals from the agency as well as AANS/CNS Committee on Drugs and Devices leaders familiar with the review process. Lectures are followed by a panel discussion with time for questions.
- Describe the current state of medical device regulation.
- Explain the steps needed to study a device in a clinical trial and the process of submitting a physician/investigator-sponsored Investigational Device Exemption (IDE).
- Identify resources available for neurosurgeons, developers and innovators.