Formatting and Submission Requirements (Tip Sheet)
Initial IDE Application Templates
- Cover Letter for Original IDE Application
- Initial IDE Application (body of application)
- Report of Prior Investigation(s) of the Device (required section of the application)
- Investigational Plan - Feasibility Study (required section of the application if a feasibility study will be conducted)
- Investigational Plan - Pivotal Study (required section of the application if a pivotal study will be conducted)
- Methods, Facilities, and Control Information (required section of the application)
- Example Investigator's Agreement (required section of the application)
Required Reports
Supplements
Q Submission
- Q Submission Program
- Study Risk Determination IDE Exempt
- Study Risk Determination Non-significant Risk
- Pre-submission Meeting Request
Form Template
Certification/Disclosure of Financial Interest of Clinical Investigators