The US Food and Drug Administration (FDA) is seeking stakeholder feedback to inform its proposed approach to regulating generative artificial intelligence (GenAI)-enabled medical devices.
With the release of a new 30-page discussion paper, the FDA highlighted that GenAI-enabled medical devices hold transformative promise for patient care and the broader health ecosystem, but noted that such devices also hold the potential to introduce unique risks when compared to traditional software and AI-enabled medical devices.
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GenAI is widely viewed as the next frontier for AI and is different to existing AI given its ability to undertake autonomous decision-making with limited or no human input.
Led by the Digital Health Center of Excellence (DHCoE), situated within the FDA’s Center for Devices and Radiological Health (CDRH), the discussion paper outlines a possible two-axis framework for risk assessment for GenAI-based medical devices that the DHCoE says may be used to inform regulatory expectations.
Regarding its approach to pre-market GenAI device evaluation, the paper outlines an approach it refers to as “competency assessment”. Inspired by how physicians are trained and evaluated, this aspect proposes using non-clinical device benchmarking and clinical confirmation to evaluate whether a GenAI-enabled medical device performs as intended before reaching patients.
For post-market monitoring, the paper sets forth considerations around foundation models and agentic AI systems. For each of these areas, the FDA poses targeted questions to inform the development of a regulatory framework that is “scientifically rigorous, prioritises patient safety, and aligns with the novel capabilities of GenAI-enabled medical devices”.
Commenting on the paper, DHCoE director Rick Abramson said: “GenAI-enabled medical devices are poised to reshape the health technology landscape, and the FDA has an important responsibility to provide thoughtful leadership for this new era.
“This discussion paper advances the frontiers of regulatory science and propels a critical conversation about how to enable beneficial innovation, protect public health, and preserve trust.”
The FDA is now encouraging feedback on the discussion paper from device manufacturers, clinicians, consumers, researchers, the public, and other interested parties until mid-October 2026.
CDRH director Michelle Tarver commented: “Patients and clinicians deserve a regulatory approach that keeps pace with the rapid innovation of digital health technologies.
“By inviting input from the public, we are launching a transparent process to inform the development of an approach that safeguards patients and consumers, advances innovation, and serves as a potential model for regulators around the world.”
The release of the FDA’s discussion paper follows the release of a similar document by the Medicines and Healthcare products Regulatory Agency’s (MHRA) in June 2026 around the future regulation of AI in healthcare as the agency works to overhaul the UK’s existing approach to regulating AI-based medical devices.
In the same month, the FDA and MHRA announced plans for a more formal collaborative approach to help shape the future of global healthcare regulation, with key focal areas of the agencies’ new liaison programme to span medical devices, AI, and innovative medicines.
