FDA Seeks Public Input on Monitoring Real-World Performance of AI-Enabled Medical Devices

The U.S. Food and Drug Administration (FDA) has launched a public consultation to gather feedback on how to measure, evaluate, and maintain the real-world performance of AI-enabled medical devices. The agency highlighted concerns about “data drift”, where AI performance can degrade over time due to changes in clinical practice, patient demographics, healthcare infrastructure, workflow integration, or user behavior. Unlike traditional medical devices, AI tools may become less reliable or biased as their environment evolves.

The consultation will be closed on Dec. 1, poses six sets of questions regarding performance metrics, real-world evaluation methods, postmarket data, triggers for additional assessments, human-AI interaction, and best practices. The FDA is seeking insights on ongoing monitoring strategies that detect, assess, and mitigate changes in device performance, with a focus on approaches currently used at scale in clinical settings. This effort aims to ensure AI-enabled devices remain safe, effective, and reliable throughout their lifecycle.

07-10-2025