FDA issues draft guidance for AI-enabled medical devices developers

Guidance addresses issues of transparency and bias, with recommendations on product design, development and documentation

The US Food and Drug Administration (FDA) issued draft guidance ─ on January 6, 2025 ─ of its recommendations to support the development and marketing of AI-enabled devices throughout its Total Product Life Cycle.

The guidance, if finalised, 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 to tie together design, development, maintenance and documentation recommendations and help ensure safety and effectiveness of AI-enabled devices.

“The FDA has authorised more than 1,000 AI-enabled devices through established premarket pathways… and it is important to recognise 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.

“The draft guidance brings together relevant information for developers, shares learnings from authorised AI-enabled devices and provides a first point-of-reference for specific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.”

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ecommendations include advice on how and when manufacturers should notify the FDA of their post market performance monitoring and management of AI-enabled products.

The recommendations reflect a comprehensive approach to risk management throughout a device’s total product life cycle.

Importantly, the draft guidance also includes the FDA’s current thinking on strategies to address transparency and bias throughout the life cycle of AI-enabled devices. The draft guidance has described particular recommendations it intends will help device manufacturers demonstrate how they have addressed any risks associated with bias and provides suggestions for thoughtful design and evaluation of AI-enabled devices.

The FDA has requested public comment on its draft guidance by April 7, 2025. In addition to general comments, the FDA has specifically requested public comment on the draft guidance’s alignment with the AI lifecycle; the adequacy of the recommendations to address concerns that may be raised by emerging technology such as generative AI; the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.

Additional Resources:

• Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations – Draft Guidance for Industry and FDA Staff
• FDA - Artificial Intelligence and Machine Learning in Software as a Medical Device
• FDA’s list of Artificial Intelligence and Machine Learning-Enabled Medical Devices
• FDA Blogs: The Promise Artificial Intelligence Holds for Improving Health Care and A Lifecycle Management Approach toward Delivering Safe, Effective AI-enabled Health Care

SOURCE: FDA