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BioWorld - Tuesday, May 13, 2025
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Home » U.S. AI med-tech regs in development 'not for the faint of heart'
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U.S. AI med-tech regs in development 'not for the faint of heart'

Aug. 23, 2019
By Mark McCarty
The FDA's regulation of artificial intelligence (AI) is divided by product center for reasons that are obvious, but precisely what that regulation will look like is anything but. As the FDA's Center for Devices and Radiological Health (CDRH) goes through the comment period for its discussion draft for AI, other nations are starting their own efforts in this space. The American agency's efforts may foreshadow the approaches employed in other nations.
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