The Food and Drug Administration's ambitious push toward artificial intelligence integration is facing significant challenges as its specialized medical device review tool struggles to perform basic tasks.
According to multiple sources familiar with the system, CDRH-GPT—an AI tool developed to assist the FDA's Center for Devices and Radiological Health in reviewing complex submissions for devices like pacemakers and insulin pumps—is encountering technical difficulties with fundamental operations including document uploads and query submissions.
"I worry that they may be moving toward AI too quickly out of desperation, before it's ready to perform," said Arthur Caplan, head of medical ethics at NYU Langone Medical Center. "It still needs human supplementation. AI is really just not intelligent enough yet to really probe the applicant or challenge or interact."
The CDRH-GPT tool was designed to help address staffing challenges following recent workforce reductions at the Department of Health and Human Services. While many device reviewers were spared from layoffs, the agency eliminated much of the backend support staff that enables timely approval decisions. The AI system was intended to help reviewers process large volumes of data from animal studies and clinical trials—work that can currently take months or even over a year to complete.
Meanwhile, FDA Commissioner Dr. Marty Makary announced on Monday that a separate AI tool called Elsa has been rolled out to all FDA employees ahead of schedule. However, sources indicate this system is experiencing issues as well. This comes despite Makary's aggressive timeline to implement AI across all FDA centers by June 30, 2025, which he announced after completing what he called a successful generative AI pilot for scientific reviewers.
"There have been years of talk about AI capabilities in frameworks, conferences and panels but we cannot afford to keep talking," Makary stated previously. "The opportunity to reduce tasks that once took days to just minutes is too important to delay."
Experts remain concerned that the FDA's rapid push toward AI integration may be outpacing the technology's actual capabilities, with potential implications for the safety and effectiveness of medical devices under review. It remains unclear whether CDRH-GPT will eventually be integrated into the Elsa system or remain standalone as the agency works to address these technical challenges before the June deadline.