This time last year, Bradley Merrill Thompson was heartbroken over the Food and Drug Administration’s decision not to prioritize guidance on artificial intelligence/machine learning (AI/ML)-enabled device software functions.
What A Difference A Year Makes; AI Makes The A-List
The US FDA’s Center for Devices and Radiological Health has announced the guidance documents it plans to focus on in fiscal year 2024, and this time, AI devices make the cut.

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