April 7, 2025
AMIA responded to the FDA's draft guidance on "Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations." We commended the FDA for its comprehensive approach to ensuring the safe and effective use of AI-enabled devices in healthcare. The comment letter emphasized the importance of transparency, bias control, and performance monitoring throughout the AI lifecycle. AMIA highlighted the need for clear guidelines on data management, algorithm updates, and continuous learning systems to maintain device safety and efficacy. AMIA also stressed the significance of stakeholder engagement, including clinicians, patients, and informatics professionals, in the development and implementation of AI-enabled devices.