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GOP Senator Wants Time Frame And Other Details On FDA’s AI/ML Action Plan

US Sen. Bill Cassidy says he wants more details about the FDA’s plans to regulate AI/ML medical software, including a time frame for publishing guidance documents.

A sign outside Louisiana Republican senator Bill Cassidy's office in Washington DC.
Sen. Bill Cassidy, R-LA, sent CDRH director Jeff Shuren a letter 10 February asking for more details on FDA's AI/ML SaMD regulatory plans (Shutterstock)

Sen. Bill Cassidy lauded the US Food and Drug Administration for its recently released artificial intelligence and machine learning software action plan, but seems to be pressing the agency step up the pace with a list of pointed questions.

The FDA’s Center for Devices and Radiological Health (CDRH) published last month a five-point action plan on how it wants...

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