Investigational Device Exemption (IDE) Templates

Formatting and Submission Requirements (Tip Sheet)

Initial IDE Application Templates

1. Original IDE Application
2. Clinical Protocol Template
3. Methods, Facilities, and Control Information
4. Example Investigator's Agreement (required section of the application)

Required Reports

1. Progress Report
2. Safety Report
3. Final Report

Supplements

1. Cover Letter for Supplemental IDE Application
2. Cover Letter for 5-Day Notification

Q Submission

1. Q Submission Program
2. Study Risk Determination IDE Exempt
3. Study Risk Determination Non-significant Risk
4. Pre-submission Meeting Request

Form Template

Certification/Disclosure of Financial Interest of Clinical Investigators