Silver Spring, Maryland, August 18, 2026
The U.S. Food and Drug Administration (FDA) has issued a new discussion paper seeking public feedback on how generative artificial intelligence (GenAI)-enabled medical devices should be evaluated and regulated. The initiative addresses critical areas including risk assessment, premarket evaluation, postmarket monitoring, foundation models, and agentic AI systems. Led by the FDA’s Digital Health Center of Excellence (DHCoE) within the Center for Devices and Radiological Health, the initiative aims to help establish a regulatory approach that supports innovation while maintaining patient safety, device effectiveness, scientific rigor, and public trust. The FDA is inviting medical-device manufacturers, healthcare professionals, researchers, consumers, and other interested stakeholders to provide feedback through a public docket.
FDA Explores Risk-Based GenAI Regulation
The rapid development of generative AI in healthcare is creating new opportunities for medical-device manufacturers and healthcare providers, while also presenting challenges that may differ from those associated with traditional software and conventional AI-enabled medical devices. The FDA’s discussion paper outlines a potential two-axis risk-assessment framework that could help determine appropriate regulatory expectations for GenAI-enabled medical devices. The approach is intended to account for the novel capabilities and potential risks associated with systems that can generate outputs, adapt to complex inputs, or incorporate advanced foundation models. By seeking input before establishing a formal regulatory framework, the FDA aims to better understand how emerging GenAI technologies should be assessed according to their potential impact on patients and healthcare decision-making. The initiative forms part of the agency’s broader efforts to advance digital health regulatory science and support responsible innovation in medical technology.
Proposed Premarket and Postmarket Approaches
The discussion paper also presents a potential approach for premarket evaluation based on the concept of competency assessment. Drawing inspiration at a high level from how physicians are trained and evaluated, the proposed approach could combine non-clinical device benchmarking with clinical confirmation to assess whether a GenAI-enabled medical device performs as intended before it reaches patients. Such evaluation could provide regulators with additional evidence regarding the reliability and performance of AI systems in healthcare environments. Beyond premarket review, the FDA is also examining potential risk-proportionate postmarket monitoring strategies. Continuous monitoring may become particularly important for GenAI technologies because of their ability to generate outputs in complex and variable situations. The agency is additionally seeking feedback on regulatory considerations for foundation models and agentic AI systems, reflecting the increasingly sophisticated architecture being incorporated into healthcare technologies.
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Public Feedback to Shape Future Framework
The FDA emphasized that the discussion paper is intended to support a transparent regulatory process and does not itself establish a final regulatory framework. Instead, the agency is asking stakeholders to respond to targeted questions that can help inform future approaches to the development, evaluation, and monitoring of GenAI-enabled medical devices. Feedback can come from device manufacturers, clinicians, consumers, researchers, and members of the public, providing an opportunity for diverse perspectives to contribute to the regulatory discussion. Comments should be submitted under docket FDA-2026-N-7874 on Regulations.gov by October 19, 2026. The initiative represents an important development for the rapidly expanding AI-enabled medical device sector, as regulators worldwide consider how existing medical-device frameworks can evolve alongside increasingly capable generative and agentic technologies. By combining innovation goals with a focus on patient safety, effectiveness, quality, accountability, and regulatory oversight, the FDA’s initiative could help shape how GenAI medical devices are developed and brought to market in the United States and potentially influence regulatory approaches internationally.
Source: FDA press relese
