FDA Seeks Public Input on Regulating Generative AI Devices

The Food and Drug Administration is requesting public feedback on how to regulate generative artificial intelligence technologies in medical devices, launching a formal comment period that runs through October 19.

The agency's Digital Health Center of Excellence published a discussion paper Tuesday addressing the regulatory challenges posed by GenAI—systems that create new content including text, images, and audio. The FDA is particularly interested in input on risk assessment frameworks, pre-market product evaluation, and post-market safety monitoring for these emerging technologies.

A risk-based regulatory framework

The FDA plans to apply its established risk-based approach to generative AI medical devices, evaluating products based on their intended use and technological characteristics. The agency aims to develop what it calls a "nimble regulatory approach" that balances patient safety with timely access to innovation.

"Generative AI-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," said radiologist Rick Abramson, MD, who became head of the Digital Health Center in February.

The discussion paper acknowledges that generative AI presents distinct risks compared to traditional software and conventional AI-enabled devices, though it holds "transformative promise for patient care and the broader health ecosystem."

Why it matters

Generative AI tools are already entering clinical workflows, from drafting radiology reports to synthesizing patient data. Without clear regulatory guardrails, healthcare organizations face uncertainty about compliance requirements while patients lack assurance about safety standards. The FDA's proactive approach could establish a global template for how regulators balance innovation velocity with patient protection in an era of rapidly evolving AI capabilities.

Broad stakeholder engagement

Michelle Tarver, MD, PhD, director of the FDA's Center for Devices and Radiological Health, emphasized the importance of public input in shaping regulatory policy. "Patients and clinicians deserve a regulatory approach that keeps pace with the rapid innovation of digital health technologies," she said.

The agency is soliciting feedback from physicians, device manufacturers, patients, researchers, and other affected parties. The discussion paper includes specific questions designed to guide respondents in formulating their comments.

The FDA stressed that the paper does not represent draft or final guidance but rather serves as a foundation for public dialogue. The agency intends the resulting framework to employ "least burdensome principles" while maintaining safety and effectiveness standards.

Interested parties can submit comments through the FDA's public docket system until October 19. The details were first reported by Radiology Business.