US FDA's AI Framework for Medical Devices

The artificial intelligence technologies granted FDA marketing authorization and cleared by the agency so far are generally called “locked” algorithms that don’t continually adapt or learn every time the algorithm is used. However, the FDA is looking beyond these elemental devices, to those capable of true AI, - machine learning algorithms that continually evolve, often called “adaptive” or “continuously learning” algorithms. Adaptive algorithms can learn from new user data presented to the algorithm through real-world use.

The FDA is exploring a framework to allow modifications to algorithms to be made from real-world learning and adaptation, while still ensuring safety and effectiveness of the software as a medical devic e(SaMD) is maintained. This webinar will discuss information specific to devices that include artificial intelligence algorithms that make real-world modifications that the agency might require for premarket review. They include the algorithm’s performance, the added concerns for AI / ML software verification…