FDA’s New AI Tool CDRH-GPT Faces Major Challenges in Beta Testing
CDRH-GPT, the FDA’s new AI tool aimed at speeding up medical device approvals, is hitting roadblocks. Sources reveal it’s buggy, struggles with simple tasks, and is not linked to the FDA’s internal systems.
The AI, designed to assist the Center for Devices and Radiological Health, has issues with uploading documents and responding to user queries. Plus, it can’t access the internet for the latest studies or data behind paywalls. 
This rollout comes amid significant staff cuts at the FDA, raising concerns about the tool’s reliability. Reviewers typically sift through massive amounts of data for device approvals, a process that can take over a year. AI was expected to help streamline this, but experts warn it may be ready too soon.
Since Dr. Marty Makary became FDA commissioner on April 1, he has been pushing AI integration across the board. He claimed the agency is ahead of schedule for a June 30 deadline, but those familiar with CDRH-GPT report it’s far from ready.
“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.
Many staff agree with Caplan. They suggest that while some AI use is worthwhile, the current aggressive rollout is premature.
Testing has revealed that when CDRH-GPT was asked about FDA-approved products, the responses were often incorrect or incomplete.
Concerns also linger about conflicts of interest. Richard Painter, a law professor at the University of Minnesota, highlighted risks if FDA reviewers have ties to AI companies.
“We need to make sure that the people involved in these decisions do not have a financial interest in the artificial intelligence companies that would get the contracts,” Painter stated.
Some FDA staff view AI not as a solution but as a looming threat to their jobs.
The FDA, already stretched thin from layoffs and hiring freezes, faces an uphill battle as it pushes AI tools that still need significant development.
