The study must contain evidence from the following: well-controlled investigations, partially controlled studies, studies and objective trials without matched controls, well-documented case histories, and reports of significant human experience with the device. The intended use of the IVD, level and quality of information in literature relevant to device use, and FDA knowledge of technology obtained from reviewing other premarket applications will be used to determine the type of study and level of evidence you need to demonstrate reasonable assurance of safety and effectiveness.
