A sponsor-investigator of a significant risk study is encouraged to contact the FDA to obtain further guidance prior to the submission of an IDE application. This will be especially beneficial to new sponsor-investigators who have not previously had contact with the agency and for sponsor-investigators proposing to study new technologies or new uses for existing technologies. By allowing the sponsor-investigator to obtain early FDA input on selected sections of the IDE application, the FDA hopes that the initiation of clinical trial will be facilitated. This communication may take the form of telephone conference calls, video conferences, or face-to-face discussions.
Refer to the FDA website for more information on the pre-IDE process.