Formatting and Submission Requirements (Tip Sheet)
Initial IDE Application Templates
- Original IDE Application
- Clinical Protocol Template
- Methods, Facilities, and Control Information
- 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