Investigator-Initiated Investigational Device Exemption (IDE) Applications

Thursday, August 27, 2026 from 11:00 AM to 12:00 PM

Join the FDA Support Team from the UH Research Support Core for an overview of how to submit and maintain Investigational Device Exemption (IDE) applications to the FDA as a sponsor-investigator.

Join the FDA Support Team from the UH Research Support Core for an overview of how to submit and maintain Investigational Device Exemption (IDE) applications to the FDA as a sponsor-investigator. 

After this session, participants will be able to: 

• Define the roles of a sponsor-investigator when conducting a study of an Investigational Device.
• Explain when an IDE is required.
• List the steps for submitting an IDE to the FDA.
• Identify Institutional resources that support sponsor-investigators.
• Explain key FDA regulatory requirements for maintaining an IDE, including safety reporting and protocol amendments.

Presenter: Erin Gorrell, PhD, RAC

HRP Competency: Regulatory Overview (Pending)

Register via UH GPS