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 constantly? What type of reference data are appropriate to utilize in measuring the performance of AI/ML software devices in the field? How much data should be provided to the Agency, and how often? How can the algorithms, models, and claims be validated and tested? How can feedback from end-users be incorporated into the training and evaluation of AI/ML-based SaMD?"
FDA has written a 5-part "action plan" for device companies with AI / ML software. It's mostly alot of words about what the FDA "wants to do", but no concrete guidelines or actionable guidance for the medical device companies. The title...
