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Podcast: US FDA’s Artificial Intelligence Guidance May Need Congress And Is At Least A Year Away, Expert Says

Zach Rothstein, the top artificial intelligence and machine learning lobbyist at device industry advocacy group AdvaMed, wrote to the US FDA with recommendations on how to regulate AI/ML devices. He sat down with Medtech Insight to break down the topic's most important issues.

AdvaMed's Zach Rothstein working at his office in Washington, D.C. As the top lobbyist for AI/ML, he's working to get US FDA on the same page as industry. • Source: Ferdous Al-Faruque

The US Food and Drug Administration will likely need legislative authority before it goes ahead with any final guidance on medical devices that use artificial intelligence and machine learning, according to Zach Rothstein, VP for technology and regulatory affairs at industry advocacy group AdvaMed. He also says the agency is currently focused on developing the precertification program, which means a guidance on AI/ML is likely at least a year away.

Earlier this year, the FDA published a discussion paper outlining how the agency is thinking about regulating software as a...

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