The FDA has released a discussion paper inviting public feedback on regulating generative AI-enabled medical devices, signaling a proactive, transparent approach to governance.

Public comments are invited from physicians, device manufacturers, consumers, researchers, and other stakeholders, with Regulations.gov open for submissions and a deadline in mid-October.

The paper is issued by the FDA’s Digital Health Center of Excellence within the Center for Devices and Radiological Health, and feedback is requested via docket FDA-2026-N-7874 on Regulations.gov.

Postmarket monitoring options are explored as risk-proportionate measures, focusing on foundation models and agentic AI to address evolving safety and effectiveness concerns.

The discussion covers risk assessment, pre-market evaluation, post-market monitoring, and considerations specific to foundation models and agentic AI systems in GenAI-enabled devices.

Topics include postmarket monitoring with attention to risk proportion and the unique challenges posed by foundation models and agentic AI within GenAI-enabled devices.

Executives say regulatory clarity will accelerate safe development and adoption of diagnostic AI in imaging, reducing uncertainty for developers, clinicians, and patients.

The agency aims to create a transparent process to safeguard patients, foster innovation, and potentially model global regulatory practices, aiming for a nimble pathway and timely patient access to safe devices.

There is concern about the downstream burden on radiologists and providers to judge model appropriateness without clear regulatory guidance, prompting calls for clearer responsibilities in deployment and ongoing validation.

FDA plans to apply a risk-based regulatory approach that weighs intended use and technological characteristics to enable a nimble yet protective framework.

The discussion paper highlights GenAI-enabled devices’ transformative potential for patient care while acknowledging risks that differ from traditional software, emphasizing a risk-based, lifecycle approach.

FDA leadership underscores the transformative potential of GenAI in healthcare while acknowledging unique risks, advocating for thoughtful regulatory leadership.