Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan (FDA website PDF)
Tiger's take-home message:
The FDA is late to the software world. As Peter Verrillo has shared in previous posts, the computational power in medical devices has grown exponentially (100X increase in 5 years), whereas the FDA has remained flat (changed at 1X in the last 5 years). They are outmatched. You can imagine that the FDA is struggling to answer a myriad of questions such as, "How does a medical device maintain Change Control for an algorithm that is changing constan...
