Artificial intelligence devices and assessment in medical imaging

Interest in the development and implementation of medical imaging devices incorporating AI/ML (artificial intelligence/machine learning) functionality has increased in recent years. There is thus a need in the community to (1) understand how the FDA regulates different types of AI/ML-enabled medical imaging devices, (2) identify the evaluation components for these devices under the FDA regulatory framework, and (3) identify unique considerations in achieving transparency for users of AI/ML-enabled devices. We provide an overview of the FDA regulatory framework and classification process for AI/ML-enabled medical imaging devices, discuss a risk-based device evaluation paradigm under this framework, and summarize the challenges and limitations of AI assessment. FDA initiatives related to AI transparency are also discussed and summarized. Although evaluation challenges remain in this fast-developing field, we hope that this chapter improves the insight into the FDA regulatory review framework and encourages all stakeholders to identify ways in which transparency might enhance the safety and effectiveness of these devices.