Investigational Device Exemption (IDE) is a provision that allows manufacturers to collect device specific safety and effectiveness data of proposed device before commercialization, which can be used to support premarket approval application or in some cases for premarket notification submission. Safety and effectiveness data is the usage data collected by monitoring a provisioned device about safety and the performance according to proposed intent. For 510(k) notification, FDA needs clinical data to provide marketing clearance in very limited cases. An approved IDE application provides rights to lawfully ship the devices for investigation purpose without forcing other FDA needs that required for device commercialization. A manufacturer must submit complete IDE application to FDA. Although, it does not have pre-determined format but they are bound to imply certain information in the form, such as sponsor investigator information, clinical plan overview, investigational plan method & controls information, and more.
