The Investigational Device Exemption (IDE) Workshop

February 17, 2023

This session is designed to look into the best practices for preparing, submitting, and maintaining sponsor-investigator INDs and IDEs.

Target Audience


Learning Objectives

This workshop will:

  • Discuss FDA’s approach to regulation of devices in clinical studies and for marketing
  • Provide guidance on when the IDE regulations apply and discuss possible exemptions
  • Review significant risk and non-significant risk device studies
  • Discuss the preparation, submission, and maintenance of IDE applications
  • Encourage participant discussion of case scenarios
Course summary
Available credit: 
  • 1.00 AMA PRA Category 1 Credit(s)
  • 2.00 Attendance
Registration Opens: 
Registration Expires: 
Activity Starts: 
02/17/2023 - 12:00pm EST
Activity Ends: 
02/17/2023 - 2:00pm EST

Kylie Opel, JD and David Jensen, PhD, RAC




Available Credit

  • 1.00 AMA PRA Category 1 Credit(s)
  • 2.00 Attendance
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