Insights

On September 30, 2025, the Food and Drug Administration (FDA) issued a Request for Public Comment (“Request”) inviting stakeholders to share practical experience and recommendations for measuring and evaluating the real-world performance of AI-enabled medical devices, including those powered by GenAI. According to FDA, the Request is not intended to communicate new guidance or regulatory expectations but aims to advance the conversation on how best to assure the safety, effectiveness, and reliability of AI-driven technologies in clinical practice.