- FDA has opened a public comment period on GenAI-enabled medical device oversight
- Comments are due Oct. 19
- The 2026 Healthcare Summit will explore AI adoption and other modernization priorities
The Food and Drug Administration has begun soliciting feedback on a discussion paper outlining considerations for regulating generative artificial intelligence-enabled medical devices.
As FDA works to shape how generative AI is regulated across the medical device landscape, government and industry leaders will gather at the Potomac Officers Club’s 2026 Healthcare Summit on Dec. 3 to discuss AI, digital tools and other priorities shaping the future of federal health technology. Reserve your spot now!
The agency said Tuesday the discussion paper supports its ‘innovation and global leadership’ strategic pillar and aligns with a broader administration priority to use AI to speed the delivery of medical products to market.
FDA is seeking input from device manufacturers, clinicians, researchers and other interested stakeholders on the paper, with public comments due through Oct. 19.
What Does the FDA’s Discussion Paper Propose for GenAI-Enabled Devices?
The discussion paper, led by the Digital Health Center of Excellence, or DHCoE, within the FDA Center for Devices and Radiological Health, outlines a two-axis framework that could be used to assess risk associated with GenAI-enabled medical devices.
The paper also describes a possible approach to premarket evaluation built around competency assessment, a concept drawn at a high level from how physicians are trained and evaluated, combining non-clinical device benchmarking with clinical confirmation to determine whether a device performs as intended before reaching patients.
Additional sections address potential approaches to risk-proportionate postmarket monitoring and considerations specific to foundation models and agentic AI systems.
What Did FDA Officials Say About the Discussion Paper?
Kyle Diamantas, acting commissioner of FDA, said AI is reshaping the practice of medicine and that the country has a responsibility to guide the technology’s development and use in a safe, accountable manner.
“Today’s announcement reflects the FDA’s commitment to advancing innovation for health care professionals and leveraging AI to improve care and patient health outcomes,” Diamantas added.
Michelle Tarver, director of FDA’s Center for Devices and Radiological Health, highlighted the need for a regulatory approach that can evolve alongside fast-moving digital health tools.
“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,” Tarver noted.
DHCoE Director Rick Abramson said the discussion paper advances the frontiers of regulatory science and supports a broader conversation on protecting public health, enabling beneficial innovation and preserving trust.
What Other Technology Initiatives Has FDA Recently Pursued?
The discussion paper builds on a series of technology moves FDA has made in recent months. In May, the agency launched Elsa 4.0 and consolidated more than 40 applications and submission systems into a new data platform called HALO, expanding the generative AI capabilities available to its reviewers.
FDA has also looked to industry for infrastructure support, seeking input in June on a planned IT infrastructure services contract built around a three-tier hybrid pricing model.
Beyond AI and IT services, the agency has continued to explore new ways of working with the private sector, proposing a venture capital-backed contracting model in December that would give portfolio companies a more direct path to compete for agency work related to public health innovation.
