The U.S. Food and Drug Administration (FDA) is offering an opportunity for stakeholders to provide feedback to “advance a broader discussion among the AI healthcare ecosystem.” Specifically, the FDA has issued a Request for Public Comment to gather insights on evaluating the real-world performance of AI-enabled medical devices, including generative AI technologies.
This initiative, detailed in Docket No. FDA-2025-N-4203, aims to ensure these devices remain safe and effective post-deployment by further evaluating challenges like data drift that may impact the accuracy and reliability of predictive models. Comments are due by December 1, 2025.
The FDA is seeking input from industry stakeholders on practical approaches to monitor and assess AI-enabled medical devices through a series of targeted questions.
Key topics include:
- Performance Metrics: Metrics used to measure safety, effectiveness, and reliability in real-world use, metric definitions, and evaluation timeframes.
- Real World Evaluation Methods: Tools and processes for proactive post-deployment monitoring, balancing human and automated review approaches, and technical and operational infrastructure used to support real-world device performance evaluation.
- Postmarket Data Sources and Quality Management: Use of electronic health records, device logs, and patient feedback for performance evaluation, addressing data quality and interoperability challenges.
- Monitoring Triggers and Response Protocols: Criteria for initiating intensive evaluations and responding to performance degradation in real-world settings.
- Human-AI Interaction: Impact of clinical usage patterns and user training on device performance, including communication strategies that have proven most effective as systems evolve.
- Additional Best Practices: Additional considerations and factors that were important in the development and implementation of real-world validation systems, implementation barriers, and strategies for patient privacy.
The FDA is allowing stakeholders to choose whether to address only specific questions or topics relevant to their business, expertise, or experience. This feedback will inform future FDA strategies to maintain the safety and effectiveness of AI-enabled medical devices throughout their lifecycle.
