ACT Brief: AI Architecture and Model Ownership Due Diligence, FDA Framework for Generative AI Medical Devices, and Heidi Overton Nominated for FDA Commissioner

Applied Clinical Trials · Aug 20, 2026 · 1m

In today's ACT Brief, we examine why AI architecture and ownership matter more than model sophistication in clinical development, how the FDA proposes to regulate generative AI-enabled medical devices, and a new leadership appointment at the agency.