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 SUBSCRIBE TO EXPONENT UPDATES 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.). AUTHORS Christie Bergerson, Ph.D. Biomedical Engineering & Sciences Manager Philadelphia (682) 367-6973 cbergerson@exponent.com Adam Sorini, Ph.D. Electrical Engineering & Computer Science Principal Scientist Menlo Park (650) 688-6914 asorini@exponent.com Elizabeth Groves, Ph.D. Data Sciences Managing Scientist Menlo Park (650) 688-7147 egroves@exponent.com RELATED PRACTICES & CAPABILITIES Biomedical Engineering & Sciences Data Sciences Electrical Engineering & Computer Science Health Sciences Machine Learning and Data Analytics Medical Device Regulatory Support Software & Computer Engineering RELATED INDUSTRIES Life Sciences & Healthcare Also of Interest Corporate Culture Subscribe To Exponent Insights News & Events Investors Contact Privacy Policy Security Statement Exponent Privacy By clicking “Accept All Cookies”, you agree to the storing of cookies on your device to enhance site navigation, analyze site usage, and assist in our marketing efforts. Privacy Policy Cookie Settings Accept All Cookies