The U.S. Food and Drug Administration's ("FDA") new advisory committee on digital health is set to examine its approach for evaluating and regulating the safety and effectiveness of medical devices utilizing generative artificial intelligence ("GenAI") at its initial meeting, receiving stakeholder insight regarding premarket performance evaluation, risk management, and postmarket performance monitoring.
FDA's new Digital Health Advisory Committee ("DHAC") will hold its first meeting on November 20-21, 2024, in Gaithersburg, Maryland, to discuss total product lifecycle considerations for GenAI-enabled medical devices, including how the use of artificial intelligence may impact the safety and effectiveness of medical devices and approaches to regulation. The newly constituted DHAC includes nine voting members; FDA may, but is not required to, supplement the DHAC with temporary, non-voting members taken from an industry representative pool.
DHAC's proposed agenda topics include:
- Premarket Performance Evaluation: What specific information related to GenAI should be available to FDA to evaluate the safety and effectiveness of GenAI-enabled devices? For example, given that foundation models leveraged by GenAI-enabled devices change over time and there may be limited available information on the training data used for these pretrained generative models, what evidence should FDA consider during premarket evaluation regarding performance and characteristics of the training data during the total product lifecycle to understand if a device is safe and effective?
- Risk Management: What new opportunities, such as new intended uses or new applications in existing uses, have been created by GenAI for medical devices, and what new controls are needed to mitigate risks? Such controls could relate to governance, training, feedback mechanisms, and real-world performance evaluation.
- Postmarket Performance Monitoring: What aspects of postmarket monitoring and evaluation will be crucial to maintain the safety and effectiveness of these devices? For example, what strategies, tools, methods, or metrics can be used to effectively monitor, manage, and evaluate the performance and accuracy of these devices?
Members of the public who cannot attend in person can still view the meeting virtually.
While a portion of the meeting will be dedicated to public speakers, FDA will consider additional public feedback made in comments to the public docket (FDA-2024-N-3924) before January 21, 2025.
Jones Day will be in attendance and plans to provide in-depth comments after the meeting.
