Templates & Forms

• Investigator Checklist for IDE Exempt, Non-Significant Risk, or Significant Risk Device Studies
• IDE Protocol Template
• IDE Protocol Cover Letter
• IDE Application Template
• IDE Certification of Financial Interest of Clinical Investigators
• IDE Application Cover Letter
• IDE Progress Report
• IDE Final Report

Useful Links

• Center for Devices & Radiological Health Documents
• Device Classification
• FAQs about IDEs
• IDE Policy
• IDE Application Required Elements
• General Requirement for the Submission of IDE Applications for Clinical Research Studies
• Marketing Your Medical Device
• Sponsor's Responsibilities for Significant Risk Device Investigations
• For IRBS: Significant Risk and Nonsignificant Risk Medical Device Studies 
• For IRBS: Frequently Asked Questions About Medical Devices 

Need assistance or have regulatory questions? Please contact CTSI Consultation Services