3. Prepare the Initial IDE Submission

1. The IDE Sponsor-Investigator compiles information in three broad areas

  • Report of Prior Investigations: Published and unpublished reports of all prior clinical, animal, and laboratory testing of the device
  • Investigational Plan: A complete written study protocol
  • Manufacturing Information: A description of the methods, facilities, and controls used for the manufacture, processing, storage, and, where appropriate, installation of the device

2. The IDE Sponsor-Investigator writes the IDE in the format of the UVA TEMPLATE – IDE     Submission (in development).  Several CTSA-awarded institutions have developed and published IDE templates for academic investigators.  The Johns Hopkins ICTR template provides an example of academic IDE formatting.

3. The IDE Sponsor-Investigator writes the IDE cover letter.  The suggested format for the cover letter is provided by the FDA here.

Contact VCTRS for support in preparing your IDE.