FDA’s Center for Devices and Radiological Health (CDRH) continued its regulatory work for generative AI (GenAI)-enabled medical devices by asking stakeholders to engage with its discussion paper on how to handle new classes of AI products. The step indicates ongoing agency effort to translate GenAI’s iterative behavior and performance variability into review and oversight frameworks. For biotech and medtech innovators, the request for input is an early signal of how evidence expectations, post-market monitoring, and lifecycle governance may be structured for AI-driven tools that can change performance over time.