A Provocative Proposal Asks the FDA to Let Some AI Devices on the Market without Review

“The proposal relies on the FDA’s ability to keep tabs on a product once it’s on the market. But according to a 2024 Government Accountability Office report, the FDA has itself recognized that its mechanisms for conducting market surveillance are ‘inadequate,’ resulting in ‘incomplete and untimely reporting, as well as underreporting of adverse events.’

The post-market monitoring infrastructure for AI at the FDA and within health systems implementing the technology, is ‘woefully insufficient,’ said Gary Weissman, who develops and studies the regulation of clinical AI/ML technologies at the University of Pennsylvania.”

Read more at STAT News.