FDA Expects List of AI/ML-Enabled Medical Devices to Grow

New database assembles publicly available information on medical devices that incorporate artificial intelligence and machine learning

November 23, 2021
On September 22, 2021, the U.S. Food & Drug Administration (FDA) released a list of artificial intelligence and machine learning (AI/ML)-enabled medical devices currently being marketed in the United States. The list includes the name of each device, the company behind it, the FDA submission number, and the date of the agency’s final decision. The current list includes hundreds of entries, and the FDA intends “to update this list on a periodic basis based on publicly available information.

This database is a first-of-its-kind public resource for medical device companies who may want to or already do incorporate AI/ML functionality into their products. The public can be slow to trust AI/ML applications in healthcare, and the industry may be hesitant to incorporate this technology into products partly due to unfamiliarity with the regulatory landscape regarding AI/ML applications in medical devices specifically. Having this information captured in a database makes interpreting the current state of the field much easier.

In the statement released with the list of AI/ML-enabled medical devices, FDA notes that it “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,” adding that the agency “expects this trend to continue.

How Exponent Can Help

Exponent has deep expertise and broad experience in medical device development and regulatory compliance. We have general expertise in software development and machine learning, as well as specific expertise in helping our clients create effective pre-market submissions and bringing medical device products that incorporate artificial intelligence/machine learning software to market (510(k), De Novo, etc.).