FDA Appoints First Chief AI Officer in Bid to Modernize Review Processes

In a significant move to embrace artificial intelligence across its operations, the U.S. Food and Drug Administration has appointed Jeremy Walsh as its first Chief AI Officer, signaling a new era in how the agency evaluates medical products and pharmaceuticals.

Walsh, who previously served as the FDA’s Digital Transformation Director, will lead the agency’s efforts to implement AI technologies throughout its review processes, according to an announcement made Wednesday. This appointment comes as the FDA faces mounting pressure to modernize its operations amid a surge in AI-enabled medical devices and digital health technologies.

“Jeremy Walsh has been instrumental in driving the FDA’s digital transformation and has demonstrated exceptional leadership in advancing the agency’s AI initiatives,” an FDA spokesperson told MedTech Dive. Walsh will report directly to FDA Principal Deputy Commissioner Dr. Namandjé Bumpus.

The appointment follows FDA Commissioner Dr. Martin Makary’s recent directive setting an aggressive June deadline for the deployment of generative AI tools across the agency. “By June, each center will have deployed GenAI internally,” Makary posted on X (formerly Twitter) on May 8, emphasizing that the technology would be used to “augment, not replace” human reviewers.

This push toward AI adoption comes on the heels of the FDA’s successful completion of its first AI-assisted scientific review pilot. The agency reported that the pilot demonstrated AI’s potential to enhance reviewer efficiency by automating routine tasks and helping identify patterns in large datasets.

“The FDA is committed to responsibly implementing AI tools to support our mission of protecting public health while fostering innovation,” the agency stated in a press release. “Our goal is to leverage these technologies to streamline regulatory processes without compromising our rigorous scientific standards.”

According to Reuters, FDA centers are expected to deploy AI tools internally “immediately,” with more comprehensive implementation planned for 2025. The agency envisions using AI for various applications, including literature reviews, data analysis, and document summarization.

Industry experts view this move as part of a broader strategy to address the FDA’s resource constraints amid an increasing workload. The agency has faced criticism for review backlogs in certain areas, particularly as submissions of AI-enabled medical technologies have grown substantially in recent years.

“The FDA is at an inflection point,” said a senior FDA official quoted by Fierce Biotech. “We must evolve our regulatory approaches to keep pace with rapidly advancing technologies while maintaining our gold standard for safety and effectiveness.”

The agency has emphasized that human reviewers will remain central to all regulatory decisions, with AI serving as a supporting tool. This approach aligns with recommendations from various stakeholders who have cautioned against over-reliance on automated systems for critical health-related determinations.

As part of this initiative, the FDA plans to establish an AI governance framework to ensure responsible implementation across its centers and offices. This framework will address ethical considerations, data security, and transparency in AI-assisted decision-making.

The FDA’s AI transformation represents one of the most significant operational changes in the agency’s recent history, potentially reshaping how medical products are reviewed and approved in the United States.