Regulatory Insights From 27 Years of Artificial Intelligence/Machine Learning-Enabled Medical Device Recalls in the United States: Implications for Future Governance.

Abstract

Artificial intelligence/machine learning (AI/ML) has revolutionized the health care industry, particularly in the development and use of medical devices. The US Food and Drug Administration (FDA) has authorized over 878 AI/ML-enabled medical devices, reflecting a growing trend in both quantity and application scope. Understanding the distinct challenges these devices present in terms of FDA regulation violations is crucial for effectively avoiding recalls. This is particularly pertinent for proa