Investigational Device Exemption (IDE) Templates

Formatting and Submission Requirements (Tip Sheet)

Initial IDE Application Templates

1. Cover Letter for Original IDE Application
2. Initial IDE Application (body of application)
3. Report of Prior Investigation(s) of the Device (required section of the application)
4. Investigational Plan - Feasibility Study (required section of the application if a feasibility study will be conducted)
5. Investigational Plan - Pivotal Study (required section of the application if a pivotal study will be conducted)
6. Methods, Facilities, and Control Information (required section of the application)
7. 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