Investigational Device Research

To request any of the templates below, please email our research navigators at ICTR_Navigators@jhmi.edu.


Guidance and Templates

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

Inquiries and Requests for Support

Please submit an ICTR Connection Request.