On November 20-21, 2024, FDA will be holding a Digital Health Advisory Committee Meeting to discuss total product lifecycle considerations for Generative Artificial Intelligence (AI)-enabled devices. This includes, for example, a discussion on how safety and effectiveness of Generative AI-enabled medical devices may be impacted as well as the following discussion question topics:  

• Premarket Performance Evaluation: Specific information that should be made available to FDA to evaluate the safety and effectiveness of Generative AI-enabled devices considering, for example, that foundation models leveraged by such devices change over time and that there may be limited information available on the training data utilized for the pretrained generative models
• Risk Management: New opportunities for medical devices (e.g., new intended uses or new applications in existing uses) that have been enabled by Generative AI and what new controls may be needed to mitigate risks associated with such technologies (e.g., controls related to governance, training, feedback mechanisms, and real-world performance evaluation)
• Postmarket Performance Monitoring: Aspects of postmarket monitoring and evaluation that will be critical to maintaining the safety and effectiveness of Generative AI-enabled devices considering such devices are non-deterministic and will undergo continuous adjustment based on localized live data, user interactions, and changing conditions

FDA also established a docket for public comment on this meeting (Docket No. FDA-2024-N-3924) which will close on January 21, 2025. Comments received on or before November 1, 2024, will be provided to the Committee and those received after will be taken into consideration by FDA.