The U.S. Food and Drug Administration has opened a public consultation to define its regulatory strategy for generative AI-powered medical devices, a move that aims to reconcile technological progress with patient safety. The agency released a discussion paper detailing proposed structures for risk evaluation, premarket review, and ongoing oversight of these sophisticated systems.
Acting FDA Commissioner Kyle Diamantas stated, “Artificial intelligence is transforming medicine, and the United States must lead in shaping how this technology is developed and used safely and responsibly.” The initiative operates under the FDA’s Digital Health Center of Excellence, which specializes in crafting regulatory standards for AI and digital health innovations.
Generative AI-enabled medical tools differ fundamentally from conventional software or predictive AI models. They introduce new safety concerns while delivering unprecedented capabilities. The discussion paper introduces a two-tiered risk assessment model and a skills-based premarket evaluation system, drawing comparisons to physician credentialing. This method blends performance benchmarks with clinical validation to ensure devices meet requirements before reaching patients.
The document also examines postmarket surveillance, foundation models, and agentic AI systems, raising targeted questions to shape a flexible regulatory framework. For instance, it explores how to assess devices generating medical outputs, such as diagnostic summaries or treatment suggestions, without depending on traditional clinical trials alone.
The FDA is inviting feedback from developers, healthcare providers, academics, and the public, with comments due by October 19, 2026, via docket FDA-2026-N-7874 on Regulations.gov. Rick Abramson, director of the Digital Health Center of Excellence, stated, “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.”
Submissions close on October 19, 2026, with the FDA planning to finalize its regulatory stance based on public input. The discussion paper does not endorse any single approach but presents options for review.
