Computer-aided diagnosis in medical imaging: Review of legal barriers to entry for the commercial systems

The goal of this paper is to explore whether the premarket regulatory system of the United States functions ideally in facing the emergence of commercial computer-aided diagnosis (CAD) systems for medical imaging. To outline the commercial CAD systems available in the United States, clinical trials published in PubMed and EMBASE from 2012 to 2016 that investigated the clinical competence of commercial CAD products were obtained, and the product information provided in these studies was searched in the Establishment Registration & Device Listing database, the Releasable 510(k) Premarket Notification database, and the Premarket Approval (PMA) database of the FDA to trace the processes through which such CAD systems entered the healthcare market. A review of current premarket regulatory system for medical devices, and the potential problems that may hinder the social and clinical integration of CAD systems are presented. We noticed expansion of regulatory definition and variation of device classes and product codes among CAD systems with similar clinical uses, which may compromise the efficacy of such regulatory controls. The results suggested ineffectiveness of current premarket regulatory controls for CAD systems in the United States.