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FDA prioritizes AI and surgical robot guidance for fiscal 2027

Rows of chairs face the stage and FDA logo screen in the Great Room of Building 31 at the U.S. Food and Drug Administration
Photo: Smith Collection/Gado/Getty Images

The FDA’s fiscal 2027 guidance emphasizes AI-enabled devices, GenAI, and surgical robots, while advancing device oversight priorities.

Among its top medical device guidance priorities for fiscal year 2027, the Food and Drug Administration (FDA) has identified artificial intelligence-enabled medical devices and robotically assisted surgical systems.

The FDA recently released its document outlining the priorities, which included a mix of high-priority files slated for drafting or finalization during the

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