FDA’s AI tool for medical devices struggles with simple tasks

A new Food and Drug Administration AI tool that could speed up reviews and approvals of medical devices such as pacemakers and insulin pumps is struggling with simple tasks, according to two people familiar with it.

The tool — which is still in beta testing — is buggy, doesn’t yet connect to the FDA’s internal systems and has issues when it comes to uploading documents or allowing users to submit questions, the people say. It’s also not currently connected to the internet and can’t access new content, such as recently published studies or anything behind a paywall.

The artificial intelligence, internally dubbed CDRH-GPT, is intended to help staffers at the agency’s Center for Devices and Radiological Health, a division responsible for ensuring the safety of devices implanted in the body, as well as essential tools like X-rays and CT scanners.

The division was among those affected by the sweeping mass layoffs at the Department for Health and Human Services earlier this year. While many of the device reviewers were spared, the agency eliminated much of the backend support that enables them to issue approval decisions on time.

The work of reviewers includes sifting through large amounts of data from animal studies and clinical trials. Depending on the applicant, it can take months or even over a year — which an AI tool could feasibly help shorten. 

Experts, however, are concerned that the FDA’s push toward AI could outpace what the technology is actually ready for. 

Since taking over the agency on April 1, Commissioner Dr. Marty Makary has pushed to integrate artificial intelligence across the FDA’s divisions. How this move into AI could affect the safety and effectiveness of drugs or medical devices hasn’t been determined.

Last month, Makary set a June 30 deadline for the AI rollout. On Monday, he said the agency was ahead of schedule. 

But the two people familiar with CDRH-GPT say that it still needs significant work and that FDA staff were already concerned about meeting the June deadline, at least in its original form. 

“I worry that they may be moving toward AI too quickly out of desperation, before it’s ready to perform,” said Arthur Caplan, the head of the medical ethics division at NYU Langone Medical Center in New York City. He stressed that reviewing medical devices accurately is essential, since people’s lives depend on it.

“It still needs human supplementation,” Caplan said. AI…