Daijiworld Media Network – Washington

Washington, Jun 4: The FDA’s new AI tool, CDRH-GPT, aimed at speeding up medical device reviews, is facing technical issues and internal skepticism, sources say.

Still in beta, the tool is reportedly buggy, can’t upload documents properly, and is not connected to FDA’s internal systems or the internet—limiting its ability to access updated studies. Despite a June 30 rollout target set by FDA Commissioner Dr Marty Makary, staff say it’s far from ready.

Makary, who took over in April, has championed AI integration across the agency. He cited another tool, Elsa, already in use for basic tasks. But staff say Elsa too has provided incorrect or partial information in early tests.

Experts warn the FDA may be moving too fast. “AI isn’t ready to replace human reviewers,” said Dr Arthur Caplan of NYU Langone. Others raised ethical concerns, including potential conflicts of interest if officials have ties to AI contractors.

With ongoing staff shortages and a hiring freeze, some employees fear AI is a step toward workforce cuts rather than support. While the agency hopes AI will improve efficiency, insiders say it still needs major work before handling life-impacting regulatory decisions.