The FDA Just Flipped The Switch On Agentic AI – And CAI Is Ready!

By Cassidy Reid and Alice Redmond

The FDA’s adoption of agentic AI signals a fundamental turning point for how regulatory work will be conducted moving forward. These systems don’t just generate outputs; they can plan, reason, and carry out multi‑step tasks under human oversight, allowing the agency to accelerate and deepen work across pre‑market reviews, post‑market surveillance, inspections, and administrative operations. As these tools take on complex workflows, the tempo and thoroughness of regulatory evaluation will increase in ways that directly affect sponsors, manufacturers, and quality teams. The real impact isn’t the sophistication of the technology. It’s the shift in expectations it creates. Organizations will need to be prepared for more responsive data requests, tighter evidence standards, and a continuous‑review mindset.

Access the full article to understand what this new reality means for regulatory engagement strategies.