Tuesday, April 28

2:00 pm - 4:00 pm

The FDA: Investigational Device Exemptions, Regulatory Process and Moving Medical Devices to Patients

Fee: $100
Advanced Practice Provider Fee: $100
Candidate and Medical Student Fee: $100

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.

Learning Objectives: After completing this educational activity, participants should be able to:
  • 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.