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.
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The US agency will host a two-day meeting to discuss the evolution of artificial intelligence technology used to analyze radiological images when diagnosing patients and in advising radiologists to take optimal pictures. The takeaways from the meeting will be used by the FDA to help it develop its thinking on how to regulate such technology.
There's A Lot On FDA’s 2020 Guidance Priorities Lists – But The Software Pre-Cert Program Isn't One Of Them
The US FDA's device center has released its annual proposed guidance document lists for fiscal year 2020. Industry experts pointed out that the lists don't address the agency's software precertification program that it has been working on so hard. That may just mean the issue has fallen off of the FDA's radar or the agency needs congressional authority to move ahead with issuing guidances on the topic, an industry expert says. Also notable is a lack of an artificial intelligence guidance.
About 130 stakeholders representing a broad spectrum of the health-care industry are asking the US FDA to consider taking a soft touch in any future guidance document addressing artificial intelligence and machine learning devices in order to keep up with developments in the field. Drug lobbyists have also asked the agency to develop guidance that reaches across centers to avoid future conflicts.