FDA Issues Draft Guidance for AI-Enabled Devices, Seeks Public FeedbackFDA Issues Draft Guidance for AI-Enabled Devices, Seeks Public Feedback

The landscape for the regulatory playing field for medical devices with artificial intelligence or machine learning has changed.

Earlier this week, FDA  issued draft guidance that includes recommendations to support the development and marketing of safe and effective AI-enabled devices throughout the device’s Total Product Life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 with an accessible set of considerations that tie together design, development, maintenance, and documentation recommendations to help ensure the 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.

Scott Whitaker, AdvaMed’s president/CEO commented on the draft guidance.

“We have been working closely with FDA on policy related to AI-enabled devices, one of our top priorities at AdvaMed,” Whitaker told MD+DI in an email. “We appreciate FDA’s ongoing work on this complex issue. We are still looking closely at the details of this draft guidance, which we hope ultimately will help and not hinder the advancement of AI in medtech. We are looking to ensure the recommendations are not too burdensome for companies, and the preference for U.S.-only data stands out as a potential concern, for example. We will address this in our public comments and in our work directly with FDA as it finalizes the guidance.”

Related:Navigating FDA’s Draft Guidance for AI-Enabled Medical Devices

FDA said the draft guidance includes recommendations for how and when, in marketing submissions, sponsors should describe the post market performance monitoring and management of their AI-enabled devices.

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 “Today’s draft guidance brings together relevant information for developers, shares learnings from authorized AI-enabled devices, and provides a first point-of-reference for specific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

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FDA is requesting public comment on this draft guidance by April 7. FDA will also hold a webinar on February 18th to discuss the draft guidance.

The agency also released draft guidance for the use of AI to support regulatory decision-making for drug and biological products.

Discussions on how to regulate AI-enabled technology have taken center stage. In May of 2024, The European Union greenlit the Artificial Intelligence Act, the most sweeping legislation to date regarding AI. However, the EU/AI Act isn’t limited to the medtech industry – it impacts every single industry that uses artificial intelligence in their products.