The FDA solicited public input on how the agency should regulate generative AI-enabled medical devices, aiming to sharpen questions around risk assessment, premarket evaluation, and postmarketing surveillance. The request frames uncertainty around how to apply existing device oversight concepts to models that can generate novel outputs. Regulators are focusing on the practical governance of these tools—how to evaluate intended use and clinical risk, and what ongoing monitoring should look like once a model is deployed. The consultation is expected to inform future guidance and oversight pathways for sponsors seeking to bring generative AI systems into clinical workflows. For biotech and medtech developers, the timing matters as more companies move from proof-of-concept into regulated product development and real-world data collection.