To request any of the templates below, please submit a DDRS service request.
IDE Application
- IDE Application Guidance and Template for Significant Risk Devices
- IDE Application Blank Template for Significant Risk Devices
eCopy Instructional Checklist
- eCopy Instructional Checklist
Letters of Authorization for 510(k) or PMA
- Guidance and Template for Letters of Authorization to 510(k) or PMA
Protocol Development Resources
- Protocol Development Guidance for Clinical Investigations Using Investigational Devices
Device Study Reporting Requirements
- NSR Device Reporting Requirements
- SR Device Reporting Requirements
IDE Study Forms
- Device Accountability Log
