The U.S. Food and Drug Administration has released a discussion paper seeking public input on how to regulate generative artificial intelligence-enabled medical devices. The agency wants feedback from manufacturers, clinicians, and the general public on specific areas including risk assessment, premarket evaluation, and postmarket monitoring. This move signals a shift toward a more structured regulatory pathway for these emerging technologies. The paper highlights that these devices may introduce unique risks when compared to traditional software and AI-enabled medical devices.
Acting FDA Commissioner Kyle Diamantas stated that the United States must lead in shaping how this technology is developed and used safely. He noted that the announcement reflects the FDA’s commitment to advancing innovation for health care professionals. The goal is to leverage AI to improve care and patient health outcomes without compromising safety standards. Diamantas emphasized the need for the technology to be developed and used responsibly within the medical field.
A New Framework for Risk and Evaluation
The Digital Health Center of Excellence, located within the FDA’s Center for Devices and Radiological Health, is leading this initiative. This effort supports the agency’s strategic pillar on Innovation and Global Leadership. Michelle Tarver, the director of the Center for Devices and Radiological Health, emphasized that patients and clinicians deserve a regulatory approach that keeps pace with rapid innovation. The pillar includes key priorities to advance regulatory frameworks for AI and 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,” Tarver said. She added that the process aims to serve as a potential model for regulators around the world. The discussion paper outlines a possible two-axis framework for risk assessment. This framework is intended to inform regulatory expectations for new devices.
The premarket evaluation concept described in the paper is inspired by how physicians are trained and evaluated. It consists of non-clinical device benchmarking and clinical confirmation. The aim is to determine whether a device performs as intended before it reaches patients. This method contrasts with traditional software validation methods, which often rely on static testing environments rather than dynamic competency checks.
Rick Abramson, the director of the Digital Health Center of Excellence, described the devices as ready to transform the medical technology sector. He noted that the FDA has an important responsibility to provide thoughtful leadership for this new era. The discussion paper advances the frontiers of regulatory science. It propels a critical conversation about enabling beneficial innovation while protecting public health. Abramson also noted that the paper helps preserve trust in the healthcare ecosystem.
Public Input and Future Directions
The paper also describes several potential approaches to risk-proportionate postmarket monitoring. It discusses considerations around foundation models and agentic AI systems. For each of these areas, the FDA poses targeted questions. These questions are designed to inform the development of a regulatory framework that is scientifically rigorous and prioritizes patient safety.
Regulators in other jurisdictions have historically struggled to keep up with the speed of software updates in medical tech. By focusing on competency assessment rather than just code review, the FDA may be attempting to address the unique variability of generative models. This approach could reduce the administrative burden on developers while maintaining a high bar for clinical performance. It aligns with the novel capabilities of these devices.
The FDA encourages feedback from device manufacturers, clinicians, consumers, researchers, and the public. Comments must be submitted under the docket FDA-2026-N-7874 on Regulations.gov. The deadline for submissions is October 19, 2026. This timeline allows for a substantial period of public review and comment before the agency finalizes its approach. The initiative supports the responsible innovation of safe and effective digital health technologies.
