Summary: The FDA released draft guidance outlining a comprehensive framework for AI-enabled devices throughout their life cycle. It details best practices in design, risk management, performance monitoring, and bias mitigation, complementing recent AI guidance. The agency seeks public feedback and will hold a webinar to discuss the proposals before finalizing them.
Key Takeaways:
- The draft guidance provides structured recommendations for AI-enabled devices—encompassing design, development, testing, and postmarket monitoring—aiming to ensure safety and effectiveness throughout their entire life cycle.
- The FDA is actively encouraging public engagement, particularly on topics like generative AI, transparency, and bias, emphasizing ongoing collaboration and refinement of these guidelines.
The U.S. Food and Drug Administration (FDA) issued draft guidance with recommendations supporting the development and marketing of safe and effective AI-enabled devices throughout the device’s Total Product Life Cycle.
Comprehensive Recommendations for AI-Enabled Devices
The guidance, if finalized, would be the first guidance to provide comprehensive recommendations for AI-enabled devices throughout the total product lifecycle, providing developers an accessible set of considerations that tie together design, development, maintenance and documentation recommendations to help ensure safety and effectiveness of AI-enabled devices. This guidance complements the recently issued final guidance on predetermined change control plans for AI-enabled devices, which provides recommendations on how to proactively plan for device updates once the product is on the market.
“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,” said Troy Tazbaz, director of the Digital Health Center of Excellence within the FDA’s Center for Devices and Radiological Health. “Today’s draft guidance brings together relevant information for developers, shares learnings from authorized AI-enabled devices and provides a first point-of-reference for specific recommendations that apply to these devices, from the earliest stages of development through the device’s entire life cycle.”
Focus on Postmarket Performance Monitoring
The draft guidance includes recommendations for how and when, in marketing submissions, sponsors should describe the postmarket performance monitoring and management of their AI-enabled devices. The proposed recommendations reflect a comprehensive approach to the management of risk throughout the device total product life cycle. The FDA encourages sponsors to engage with the agency early and often, and to use this guidance, once finalized, to guide their activities throughout the life cycle of the device, including during planning, development, testing and ongoing monitoring.
This draft guidance also includes the FDA’s current thinking on strategies to address transparency and bias throughout the life cycle of AI-enabled devices. The draft guidance describes specific recommendations intended to help a sponsor demonstrate they have addressed risks associated with bias and provides suggestions for the thoughtful design and evaluation of AI-enabled devices.
Additional Guidance for Drug and Biological Products
The FDA also published draft guidance with recommendations regarding the use of AI to support development of drug and biological products.
The FDA is requesting public comment on this draft guidance by April 7, 2025. In addition to general comments, the FDA is specifically requesting public comment on the draft guidance’s alignment with the AI lifecycle; the adequacy of the recommendations to address concerns that may be raised by emerging technology such as generative AI; the approach to performance monitoring (including use of a performance monitoring plan as a means of risk mitigation for AI-enabled devices); the type of information about AI-enabled devices that should be conveyed to users and the most appropriate approach to deliver that information. The FDA will also hold a webinar on February 18, 2025, to discuss the draft guidance.
