FDA 101: A Primer on IDEs

What does it take for developers and innovators to study higher-risk medical devices in clinical trials? This UB CTSI Educational Modules video focuses on Investigation Device Exemption (IDE) studies and explores:

  • The differences between IDE study types: Early Feasibility Study, Traditional Feasibility Study, and Pivotal Study
  • Why and how to seek FDA guidance
  • How to navigate the FDA’s expectations for developers

Developed and presented by Carlos Peña, PhD, MS, Chief Regulatory Officer/Chief Quality Officer, Jacobs Institute

Running Time: 8 minutes

Posting Date: April 13, 2022

Questions?

Contact Carlos Peña, PhD, MS, Chief Regulatory Officer/Chief Quality Officer, Jacobs Institute, at cpena@jacobsinstitute.org.

Additional resources:

“Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff”: https://www.fda.gov/media/114034/download