IDE Preparation

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Develop the IDE Study Protocol
The IDE Protocol is the basis for both the IRB Application and the initial IDE submission:

  • Review the attached protocol template for required content.  A completed protocol and cover letter must be included in the IDE application.
  • Start with a protocol synopsis (page 7 and 8 of the protocol template).   The protocol synopsis will be valuable if you are planning a pre-IDE meeting.   
  • Compile a reference list. Include all published articles and unpublished reports or manuscripts cited.  Collect a copy of each article or report listed.

Prepare the Initial IDE Submission
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 Published and unpublished reports of all prior clinical, animal, and laboratory testing of the device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
  • The IDE Sponsor-Investigator writes the IDE Application (including the Investigators Certification of Financial Interest) and the IDE Cover Letter.

Need assistance or have regulatory questions? Please contact CTSI Consultation Services