In this third article of a three-article series on interviews with Dr Shantanu Nundy, an advisor in the office of the Commissioner of the US FDA on AI governance and digital health policy, we explore how the oversight of generative AI (GenAI) and large language model (LLM)-enabled medical devices extends beyond the remit of any single regulator, requiring coordination among government agencies, health systems, and practicing clinicians. We also discuss practical advice for innovators seeking to engage productively with the FDA.
Gilbert et al. (Fri,) studied this question.