As AI Device Market Grows, FDA’s Accounting Goes Silent

“In December, as the Food and Drug Administration was finalizing an avalanche of last-minute regulatory guidelines before President Trump’s inauguration, it quietly passed a major milestone. A regularly-updated list from its device center showed the FDA had authorized more than 1,000 devices enabled by artificial intelligence and machine learning, mirroring the rapid growth of the technology in health care.

In the six months since, as the federal government has moved to deregulate the field of AI, the FDA’s list of AI/ML device authorizations has gone untouched. […]

The FDA did not respond to multiple requests about plans to update its public accounting of AI/ML-based devices. If the list continues to go without updates, ‘it would make it much harder to track FDA authorizations for AI/ML devices, thereby impairing transparency and public trust,’ said Gary Weissman, who develops and studies the regulation of clinical AI/ML technologies at the University of Pennsylvania. It would also make it harder for researchers like him to do their work.”

Read more at STAT News.