Summary: The FDA released draft guidance outlining a comprehensive framework for AI-enabled devices throughout their life cycle.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  • The draft guidance provides structured recommendations for AI-enabled devices—encompassing design, development, testing, and postmarket monitoring—aiming to ensure safety and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The U.S.FDA has issued draft guidance with recommendations supporting the development and marketing of safe and effective AI-enabled devices throughout the device’s Total Product Life Cycle.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

If finalized, the guidance would be the first to offer comprehensive recommendations for AI-enabled devices across their entire lifecycle, covering design, development, maintenance, and documentation to ensure safety and effectiveness. It complements recent guidance on predetermined change control plans, which advises on planning updates for AI-enabled devices after they reach 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,” says 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“Today’s draft guidance brings together relevant information for developers, shares learnings from authorized AI-enabled devices and provides a first point-of-reference for specific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,” he adds.

Focus on Postmarket Performance Monitoring

The draft guidance advises sponsors on describing postmarket performance monitoring and management of AI-enabled devices in marketing submissions, emphasizing a comprehensive approach to risk management throughout the product lifecycle. The FDA encourages early and frequent engagement with the agency and recommends using the finalized guidance to inform planning, development, testing, and ongoing monitoring.

It also outlines strategies to promote transparency and address bias in AI-enabled devices. Specific recommendations help sponsors demonstrate efforts to mitigate bias-related risks and ensure thoughtful design and evaluation.

Additional Guidance for Drug and Biological Products

The FDA has also released draft guidance on using AI to support drug and biological product development and is seeking public comments by April 7. The agency is particularly interested in feedback on the draft guidance’s alignment with the AI lifecycle, the adequacy of its recommendations for addressing concerns related to emerging technologies such as generative AI, and its approach to performance monitoring, including the use of monitoring plans to mitigate risks in AI-enabled devices.

The FDA is also requesting input on the type of information about AI-enabled devices that should be shared with users and the most effective ways to deliver that information. A webinar to discuss the draft guidance is scheduled for February 18.