FDA Panel Meeting To Focus On AI/ML Device Labeling, Transparency

The US agency will host an October public workshop to get stakeholder input in developing a much-anticipated artificial intelligence/machine learning draft guidance.

Robot holding a hologram screen

The US Food and Drug Administration is hosting a virtual public workshop on 14 October to discuss transparency of artificial intelligence/machine learning (AI/ML) in medical devices. The meeting is the latest step in the agency’s work to develop a new regulatory framework for AI/ML products.

The gathering is in direct response to stakeholder feedback, including from the FDA’s Patient Engagement Advisory Committee (PEAC) on AI/ML-enabled medical devices from October 2020, the FDA says. Following the meeting the agency published a five-part action plan on AI-ML medical devices that proposed holding a public workshop

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