The U.S. FDA’s Center for Devices and Radiological Health (CDRH) continued its GenAI regulatory discussion by inviting stakeholders to comment on a recently released discussion paper. The agency is seeking feedback on the regulatory challenges posed by generative AI-enabled medical devices. The outreach comes as regulators work to define expectations for device safety, performance, and oversight for models that can generate outputs beyond fixed algorithms. The discussion paper sets the stage for how FDA may treat model development, validation, and post-market considerations. For biotech and digital health teams, the stakeholder process provides a near-term pathway to influence how generative AI medical products are evaluated and monitored in practice.