Summary: The FDA has issued draft guidance that provides recommendations for the development, marketing, and postmarket management of AI-enabled medical devices throughout their total product life cycle. The guidance aims to address unique considerations for AI, including transparency, bias, and performance monitoring and encourages early and frequent engagement with the agency. Public comments on the guidance are requested by April 7, 2025, and a webinar is scheduled to discuss the recommendations.
Key Takeaways:
- Comprehensive AI Device Guidance: The FDA’s draft guidance outlines recommendations for managing AI-enabled devices from design and development through postmarket performance, addressing safety, effectiveness, and risk mitigation.
- Focus on Transparency and Bias: The guidance includes strategies to address risks associated with bias and promotes transparency throughout the device life cycle to ensure equitable and reliable performance.
- Call for Public Input: The FDA is soliciting comments on the draft guidance, particularly on its alignment with the AI life cycle, strategies for managing emerging technologies like generative AI, and approaches to performance monitoring and user communication.
The US Food and Drug Administration (FDA) issued draft guidance that includes recommendations to support development and marketing of safe and effective AI-enabled devices throughout the device’s Total Product Life Cycle.
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.
FDA Highlights Considerations for AI-Enabled Devices
“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,” says Troy Tazbaz, director of the Digital Health Center of Excellence within the FDA’s Center for Devices and Radiological Health, in a release. “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.”
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.
Addressing Transparency, Bias, and Risk Management
Importantly, 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.
This announcement is specific to AI-enabled devices. Today, the FDA also published draft guidance with recommendations regarding the use of AI to support development of drug and biological products.
Public Input and Next Steps
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 Feb 18, 2025, to discuss the draft guidance.
ID 135634014 | Ai © ProductionPerig | Dreamstime.com
