Overview
If a planned clinical trial of a device does not qualify for IDE exemption, and the IRB or FDA does not believe the use of the device is Non-Significant Risk (NSR), the investigator should follow the steps below to prepare an IDE application for submission to FDA.
Step1
Draft the IDE Study Protocol.
A fully developed clinical protocol is the basis for both the IRB application and the initial IDE submission to FDA.
Drafting Your IDE Study ProtocolStep2
Prepare the Initial IDE Application Components.
IDE submissions must include all six required components.
Preparing the Initial IDE Application ComponentsStep3
Submit the Initial IDE to the FDA
All forms completed during the initial IDE submission process must be assembled into one IDE application packet.
Submitting Your Initial IDE