The Trump administration is reinstating some employees in the Food and Drug Administration's medical devices division after dozens were laid off as part of a government-wide cost-cutting initiative ...
The FDA formally kicked off its quinquennial process to reauthorize the federal user fee legislation that helps fund its medical device reviews by hosting discussions with the medtech industry and ...
In November, the Food and Drug Administration (FDA) held a Digital Health Advisory Committee meeting where it considered treating artificial intelligence mental health chatbots as medical devices. As ...
The Food and Drug Administration (FDA) published new guidance for AI-enabled medical devices on January 7, 2025. These are nonbinding and not for implementation. The public comment window for these ...
To support the continued development and marketing of safe and effective medical devices enhanced by artificial intelligence, the U.S. Food and Drug Administration will offer marketing submission ...
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