This DPA R&STF special session convenes FDA and industry leaders to advance digital pathology regulatory science and consensus standards. The session opens with a review of R&STF’s annual achievements by Chair Dr. John Groth (Endeavor Health), followed by a presentation from Dr. Aldo Badano (FDA) on the FDA/DPA collaboration exploring scientific approaches for technical performance assessment. A multidisciplinary panel, moderated by Cheng Cui (AstraZeneca), will then explore three key themes: evaluation approaches for WSI systems, the establishment of robust validation methods for computational pathology-based devices, and strategies for AI-enabled biomarker and companion diagnostic validation to align with current FDA considerations for data strategy and clinical validation in premarket applications.