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- Report of Prior Investigations: Published and unpublished reports of all prior clinical, animal, and laboratory testing of the device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.