The evaluation of computer-aided diagnosis systems: an FDA perspective

Abstract

Computer-aided diagnosis (CADx) systems have begun a successful transition from academic research to commercial implementation. FDA (Food & Drug Administration) approval of CADx for PAP (Peroxidase-Antiperoxidase) smear reading in 1995 and for breast cancer detection in 1998 were major milestones in this process. As agency experience with these devices has increased, a consensus is emerging concerning factors to be considered in the evaluation required during the approval process. Key elements determining the nature of the proof of safety and effectiveness required by the agency include the intrinsic level of risk associated with the device and the medical condition that it is meant to address, the precise claims made for the device and the degree of oversight exercised over its use. The agency expects that an increasing number of CADx devices will be submitted to it in the future and that guidelines will have to be formulated to assist manufacturers in navigating the approval process.