Developing a GenAI-enabled medical device? Implementing GenAI in a healthcare application? Curious to hear how FDA is thinking about regulating in this rapidly-developing space? Want to understand the perspectives that will influence anticipated regulations at the ground level? If you answered yes to any of these questions, you will likely want to tune into FDA's upcoming Digital Health Advisory Committee meeting on premarket evaluation, risk management, and postmarket monitoring.  As innovation continues to outpace regulation in this area, it is especially important for companies developing or marketing healthcare products that utilize AI technology to stay abreast of FDA’s thoughts on how to regulate these products, as this will play into development, use cases and potentially even product liability considerations down the road.

Committee materials and the web link for the November 20 & 21 meetings are included below. The meetings are open to the public and those interested can attend in person in Maryland, or virtually through Webcast. The FDA is also establishing a docket for public comment on this meeting, with comments due by January 21, 2025.