The U.S. Food and Drug Administration has taken a significant step forward in regulating artificial intelligence in healthcare by issuing draft guidance for AI-enabled medical devices. This comprehensive framework aims to support the development and marketing of safe and effective AI devices throughout their Total Product Life Cycle, marking the first guidance of its kind to address the complete product journey.
"The FDA has authorized more than 1,000 AI-enabled devices through established premarket pathways. As we continue to see exciting developments in this field, it's important to recognize that there are specific considerations unique to AI-enabled devices," stated Troy Tazbaz, director of the Digital Health Center of Excellence within the FDA's Center for Devices and Radiological Health.
The guidance provides developers with specific recommendations across multiple areas, including device design, development, maintenance, and documentation. It complements the recently issued final guidance on predetermined change control plans for AI-enabled devices, offering a framework for proactive planning of device updates post-market launch.
Key aspects of the draft guidance include recommendations for post-market performance monitoring and management of AI-enabled devices in marketing submissions. The document emphasizes a comprehensive approach to risk management throughout the device lifecycle and encourages early and frequent engagement with the FDA.
Notably, the guidance addresses critical issues of transparency and bias in AI-enabled devices, providing specific recommendations to help sponsors demonstrate their approach to managing these risks. The FDA is actively seeking public comment on various aspects of the guidance until April 7, 2025, including its alignment with the AI lifecycle and its adequacy in addressing emerging technologies like generative AI.
The agency has scheduled a webinar for February 18, 2025, to discuss the draft guidance in detail. This initiative runs parallel to separate draft guidance focused on AI use in drug and biological product development, demonstrating the FDA's broader commitment to supporting innovation while ensuring product safety and effectiveness in the rapidly evolving field of AI-enabled healthcare solutions.
Click here for the original FDA press announcement.