Post-Market Responsibilities for Medical AI: Part I – FDA's Plan to Increase Its Oversight

There is an elephant in the room. Tension in the air that we need to discuss. FDA is trying to convince artificial intelligence developers in healthcare to let the agency have much broader power and authority over marketed products than the agency presently does in exchange for, FDA suggests, faster premarket review times. My advice to industry? Don’t do it. Don’t agree to regulatory changes that would give FDA expanded post-market powers. It won’t be worth it.
To be clear, I’m not giving this advice simply because FDA has failed to quantify any premarket advantage, whether in terms of reduced evidence required for submission to the agency or speedier reviews. Instead, this is my advice simply because the cost of giving FDA expanded postmarket authority would be too much to pay. While I agree expanded vigilance is indeed necessary when commercializing medical AI that can adapt to new data, I urge the medical AI industry to be proactive in accepting responsibility for their own postmarket monitoring and continuous improvement, in lieu of increased FDA oversight.
This is a big topic, so I’m dividing it into three different parts that will be published separately. What follows in this post is part one, where I provide the background on FDA’s plans to ask Congress for more legal authority to regulate the marketing of medical AI. Among other things, for context, I will describe FDA’s existing authority, and I will address the standard by which we should evaluate whether expanded regulatory oversight is best for the patient. The second part will focus on what medical AI developers should do now to take responsibility for marketing medical AI. In other words, I’ll talk about best practices that it’s my hope industry will adopt. Then third, in my final post I will make the case why Congress should not give FDA expanded oversight of medical AI commercialization.
A. FDA’s Existing Postmarket Role
For context, it’s important to understand that FDA already has a substantial role overseeing the commercialization of medical devices, but it is a legally constrained one. Here is a very high-level summary of some of FDA’s more significant, relevant legal authorities over medical products in the marketplace …