AMIA Comments on FDA Real-World Performance Monitoring and Equity Assessment of AI-Enabled Medical Devices

AMIA commented on FDA's request for public comment regarding real-world performance evaluation of AI-enabled medical devices. We support lifecycle governance with continuous post-market monitoring to address performance drift across diverse populations and settings. AMIA recommends comprehensive metrics beyond accuracy including clinical outcomes, safety, usability, and equity assessment. We emphasize transparent documentation, bias mitigation to prevent health disparities, and cross-institutional data sharing for aggregate reporting. AMIA's comments mainly referenced the Association's Public Policy Principles and CHAI's Responsible AI Guide for trustworthy healthcare AI.

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AMIA Measuring and Evaluating AI Med Devices FDA RFPC