FDA seeks feedback on regulating AI-enabled medical devices
The U.S. Food and Drug Administration is seeking public feedback on the regulation of artificial intelligence-enabled medical devices.
On Tuesday, the agency issued a formal request for comment on attempts to measure and evaluate how such technologies perform in the real world. It’s setting a Dec. 1 deadline, also asking for advice on approaches to detect, assess and mitigate AI performance changes over time, ensuring that devices “remain safe and effective throughout their life cycle.”
“AI, including [generative AI], presents opportunities to improve patient outcomes, advance public health and accelerate medical innovation,” the FDA said in an announcement Sept. 30. “At the same time, these technologies introduce new considerations … particularly with respect to assessing their performance, safety and reliability after deployment in real-world settings.”
The request is aimed at building on insights discussed during the November 2024 meeting of the FDA Digital Health Advisory Committee. At the time, AI stakeholders discussed strategies to evaluate AI devices in clinical practice, with the goal of ensuring they remain effective following deployment. The FDA highlighted the issue of “data drift,” which can potentially lead to degradation, bias or reduced reliability.
“Currently, many AI-enabled medical devices are evaluated primarily through retrospective testing or static benchmarks,” the agency added. “While these methods may help establish a baseline understanding of the medical device performance, they are not designed to predict behavior in dynamic, real-world environments.”
The FDA posted a series of questions to aid commenters in formulating their thoughts. Examples include: What metrics or performance indicators do you use to measure the safety, effectiveness and reliability of AI-enabled medical devices? How are these metrics defined and weighted when assessing different dimensions of performance and safety? And what timeframe do you consider when evaluating real-world clinical performance?
You can find further questions, and instructions on how to submit comments, in the FDA notice here.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.