On August 18, 2026, the U.S. Food and Drug Administration (FDA) announced a formal request for public feedback concerning the regulatory approach for generative AI-enabled medical devices. This initiative aims to gather insights that will inform the future regulation of these advanced technologies within healthcare. The solicitation invites input from healthcare professionals, manufacturers, and institutions involved with the incorporation of artificial intelligence in clinical care. The FDA emphasizes the importance of stakeholder engagement to address the regulatory considerations associated with generative AI in medical devices. This time-bound request reflects the FDA's commitment to developing a regulatory framework that ensures the safety and effectiveness of AI-enabled medical technologies, while facilitating innovation in patient care. Participants are encouraged to provide detailed feedback that will help shape policies in this evolving area.