The form and content of preliminary investigational device exemptions submissions will be presented. Early and consistent communication with the agency is encouraged in order to facilitate progression into clinical studies. This cooperative effort may be implemented through teleconferences, meetings, and/or written submissions. The extent of these interactions may be dependent on the complexity and novelty of the device and related issues. Product development is a dynamic process and interaction with the agency may be initiated at any of several stages in this developmental process. The basic level of information which should be presented by the sponsor will be discussed. This basic information should serve as a foundation for development of a testing strategy for the device. In order to identify both safety and efficacy issues with a device it is first necessary to describe the device and its intended use. Given this information, it is then possible to conduct an analysis of the potential failure modes and identify potential issues. Thus, a rationale/justification for the developmental strategy should be provided and based upon anticipated safety and effectiveness. A working example of the preclinical in vivo/clinical level of information necessary for the evaluation of a Fantasy Endovascular Device System (FEDS) will be presented.