The agency is asking for public input on risk assessment, pre-market review, and post-market monitoring.
Agency leaders stress safe innovation
Acting FDA Commissioner Kyle Diamantas, J.D. said artificial intelligence is reshaping medicine and the United States must guide its safe use. “Today’s announcement reflects the FDA’s commitment to advancing innovation for health care professionals and leveraging AI to improve care and patient health outcomes,” he stated.
The Digital Health Center of Excellence within the FDA’s Center for Devices and Radiological Health is drafting the paper. The draft aligns with the agency’s Public Health Pillar on Innovation and Global Leadership, which aims to update regulatory frameworks for AI and digital health tools.
Center Director Michelle Tarver, M.D., Ph.D. emphasized the need for a regulatory approach that matches the speed of digital health advances. “Patients and clinicians deserve a regulatory approach that keeps pace with the rapid innovation of digital health technologies,” she said, adding that public input will help shape a transparent process.
DHCoE Director Rick Abramson, M.D. noted the responsibility to guide this new era.
Proposed framework and evaluation methods
The paper proposes a two-axis risk-assessment model to set regulatory expectations. It also suggests a pre-market evaluation based on a competency-assessment concept, likening the process to physician training and assessment.
Under this approach, manufacturers would conduct non-clinical device benchmarking followed by clinical confirmation to demonstrate that the device performs as intended before patient use.
For post-market oversight, it outlines risk-proportionate monitoring strategies and raises questions about the use of foundation models and agentic AI systems. These considerations aim to address ongoing safety and performance issues once devices enter the market.
The agency invites feedback from manufacturers, clinicians, consumers, researchers, and other stakeholders. Comments should be submitted to docket FDA-2026-N-7874 on Regulations.gov by October 19, 2026.
