FDA Official Believes GenAI-enabled Tools Will Need to Be Assessed Like a Physician

Rick Abramson, director of the FDA's Digital Health Center of Excellence and a radiologist, stated that generative AI-enabled medical tools may require regulatory assessment frameworks distinct from traditional devices. Abramson suggested these tools behave more like physician decision-support systems than conventional hardware, implying the FDA may need to adapt its approval and oversight approach for AI-driven diagnostics and clinical software.