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Investigational Device Research

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