FDA Finalizes PCCP Guidance for AI-Enabled Medical Devices

On May 12, 2026, the Food and Drug Administration (FDA) published a notice in the Federal Register requesting comment on the agency’s efforts related to drug repurposing to help address unmet medical needs. In this request for information (RFI), FDA is seeking input to identify potential new uses for FDA-approved drugs—such as a new indication or a new population—to help accelerate the availability of treatments for unmet medical needs. Stakeholders are encouraged to submit priority disease areas and potential candidates for drug repurposing, particularly in cases where there is a lack of commercial incentive to pursue labeling changes or a significant unmet need.

As medical chatbots proliferate, a new Pennsylvania lawsuit highlights a developing trend of states leading health artificial intelligence (AI) enforcement efforts, while the Food and Drug Administration (FDA) appears to be on the sidelines.

On May 12, 2026, the U.S. Food and Drug Administration (FDA) announced a major milestone in its approach to post-market oversight of chemicals in the food supply, finalizing a new proactive food chemical safety post-market assessment program and releasing two foundational papers: the “Enhanced Systematic Process for Post-Market Assessment of Chemicals in Food” and the “Tool for the Prioritization of Food Chemicals for Post-Market Assessment.”

In December 2016, the bipartisan 21st Century Cures Act (P.L. 114-255) was enacted, marking a pivotal milestone in advancing a patient-focused drug development (PFDD) paradigm. This law directed the Food and Drug Administration (FDA) to develop and implement strategies to solicit view of patients during the medical product development process and consider the perspectives of patients during regulatory discussions. Over the past decade, FDA has steadily taken steps to implement the 21st Century Cures Act patient-focused drug development provisions, including through meetings by which patients, caregivers, family members and patient advocates, among others, have been able to provide information about patients’ experiences with a disease or condition. The opportunity to provide such feedback through these patient-focused meetings is a key pillar of the agency’s patient-focused drug development engagement.