A senior FDA official said GenAI-enabled medical devices may need to be assessed in a manner closer to how physicians are evaluated, rather than treated like classic stand-alone equipment such as heart valves. The statement came from Rick Abramson, director of the FDA’s Digital Health Center of Excellence. The comment suggests an emphasis on how AI tools behave in realistic clinical workflows, including interactions with users and decision-making context. It also points toward assessment paradigms that consider system-level performance and safety rather than purely model-technical benchmarks. For developers, the message raises the likelihood that regulatory pathways will focus on clinical behavior, robustness, and human factors—especially where outputs influence diagnosis, triage, or treatment planning decisions.