From time to time, a regulatory announcement lands that signifies a major change. FDA’s recent decision to deploy agentic AI capabilities across the agency is one of those moments. (Read a detailed analysis on page 43.) For medical device designers and engineers, this shift isn’t happening on the sidelines. It’s at the center of the industry’s future.
In its announcement, FDA described agentic AI as a new class of systems that can plan, reason, and execute multi-step tasks with built-in guardrails and human oversight. In other words, these tools go far beyond familiar single-query AI assistants. They’re designed to help staff navigate complexity while preserving trust and data integrity. “There has never been a better moment in agency history to modernize with tools that can radically improve our ability to accelerate more cures and meaningful treatments,” says FDA Commissioner Marty Makary, MD, MPH.
Coming from an agency often perceived as risk-averse by design, this is an unusually forward-leaning message. This shift is significant.
In May 2025, the agency deployed its first internal large language model, Elsa. With more than 70 percent of staff adopting the tool voluntarily, it quickly reshaped day-to-day work and demonstrated that regulators embraced the technology. Now, the move into agentic AI suggests a second phase: integrating AI into entire workflows, not just parts of the process.
FDA’s list of target applications could be a blueprint for modernization: meeting management, premarket reviews, validation steps, postmarket surveillance, inspections, compliance, and even administrative tasks. These are precisely the areas where review bottlenecks, document complexity, and sheer volume has historically slow ed progress for medtech innovators.
What should medtech teams take away from this? First, that FDA is positioning itself to evaluate innovations more efficiently — not by easing requirements, but by strengthening the tools used to evaluate risk and benefit. Second, medtech innovators should note that AI-enhanced regulatory science will increasingly favor companies that build strong data foundations, traceability, and documentation practices.
And finally, the agency’s new Agentic AI Challenge — culminating in demonstrations at Scientific Computing Day in January 2026 — signals that FDA staff themselves will help shape the next chapter of AI-driven regulation.
If regulators are accelerating their digital transformation, the medtech community must be ready to meet them there.
Sherrie Trigg
Editor and Director of Medical Content
