The U.S. Food and Drug Administration has released draft guidance aimed at ensuring the safe and effective development, marketing, and lifecycle management of AI-enabled medical devices. If finalized, this will be the first comprehensive guidance covering all stages of an AI-enabled device’s lifecycle, from design and development to maintenance and documentation. The guidance aligns with the agency’s recent recommendations on predetermined change control plans, which help developers prepare for post-market updates. The FDA has authorized more than 1,000 AI-enabled devices through established premarket pathways and emphasizes the importance of addressing risks unique to AI, including bias and transparency. Developers are encouraged to use the guidance throughout the lifecycle of their devices and to engage with the FDA early in the process.
The draft guidance outlines recommendations for post-market performance monitoring and risk management, ensuring that AI-enabled devices maintain safety and effectiveness after they reach the market. The FDA is seeking public comments on the guidance by April 7, 2025, specifically regarding its alignment with the AI lifecycle, performance monitoring strategies, and communication of AI-related information to users. A public webinar is scheduled for February 18, 2025, to discuss the draft recommendations. This initiative reflects the FDA’s ongoing commitment to balancing innovation with safety in AI-driven healthcare solutions.