U.S. Food and Drug Administration
As technology continues to advance every aspect of health care, software incorporating artificial intelligence (AI), and specifically the subset of AI known as machine learning (ML), has become an important part of an increasing number of medical devices. One of the greatest potential benefits of ML resides in its ability to create new and important insights from the vast amount of data generated during the delivery of health care every day.
Interest in medical devices incorporating ML functionality has increased in recent years. Over the past decade, the FDA has reviewed and authorized a growing number of devices legally marketed (via 510(k) clearance, granted De Novo request, or approved PMA) with ML across many different fields of medicine—and expects this trend to continue.
The FDA is providing this initial list of AI/ML-enabled medical devices marketed in the United States as a resource to the public about these devices and the FDA’s work in this area.
