October 5, 2021

List of Artificial Intelligence and Machine Learning (AI/ML)-enabled Devices Available on FDA’s Website

The U.S. Food and Drug Administration (FDA) now provides a list of Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices that are legally marketed in the United States. These include devices (1) cleared via 510(k) premarket notifications, (2) authorized pursuant to De Novo requests, and (3) approved via premarket approval applications, or PMAs. FDA explains that the list, developed by FDA’s Digital Health Center of Excellence, while not exhaustive or comprehensive, is intended to increase transparency and access to information on these devices that span across medical disciplines. With interest increasing dramatically in this area and with over 300 devices dating back to 1997, this list is a helpful tool to identify the many AI/ML-enabled devices currently legally available. FDA intends to update this list periodically.

The FDA has also announced a virtual public workshop on transparency of Artificial Intelligence/Machine Learning (AI/ML)-enabled medical devices to patients, caregivers, and providers, scheduled for Thursday, October 14.