Investigational Device Exemption Process

This section provides comprehensive information for investigators that helps determine whether or not an IDE is needed for the proposed study, the process of applying for an IDE with the FDA, and the responsibilities of investigators who hold IDEs. Additionally, the IND/IDE Support Office is a resource for investigators who would like to consult with us regarding study design as it may pertain to the necessity of an IDE.

Resources

• IDE Training Slide Deck
  • Part 1 - Devices Overview and Sponsor IDE Application Training
  • Part 2 - Sponsor-Investigator Responsibilities IDE Training
  • Part 3 - Trial Master File Essential Documents
  • IDE Training Supplement
• Templates
  • IDE Application Template
  • IDE Annual Report Cover Letter Template
  • IDE Annual Report Template
  • IDE Investigator Agreement Template
  • IDE 6 Month Report Template
  • IDE Final Report Template
  • IDE Withdrawal Cover Letter Template
  • IDE Exemption Checklist
• Compassionate Use Device Checklist
• FDA Guidance Regarding Expanded Access for Medical Devices
• Humanitarian Use Device Checklist