Computer-Aided Detection/Diagnosis in Breast Imaging: A Focus on the Evolving FDA Regulations for Using Software as a Medical Device

Artificial Intelligence (AI)-based computer-aided detection (CAD) applications for medical tasks are classified by the Food and Drug Administration (FDA) as medical devices. The purpose of this paper to review CAD and its categories, explain why AI counts as a medical device, and describe its FDA approval process. The review will also include some of the recent advancements in AI-based CAD for different modalities in breast imaging. To keep up with the rapid pace of AI, changes have recently been made by the FDA in how CAD software is classified and regulated. The expedited 510(k) FDA approval pathway has facilitated the expansion of AI-based imaging applications with faster access to the most up-to-date technologies. However, gaps may remain in the FDA process for vigorous quality testing to approve such products