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BioWorld - Monday, April 13, 2026
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Home » FDA aims to navigate treacherous AI regulatory waters
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FDA aims to navigate treacherous AI regulatory waters

Feb. 25, 2020
By Mark McCarty
Developers of artificial intelligence (AI) algorithms have their own nightmares to deal with, but the FDA is charged with employing a regulatory touch that steers clear of rocky shoals on one side and inescapable whirlpools on the other. The FDA’s Bakul Patel said during a Feb. 25 workshop that the FDA would quickly be swamped if the agency took a traditional regulatory approach to managing the super-iterative digital health space, but that the agency will keep a keen eye on the potential impact on patients as AI begins to move into clinical practice.
Medical technology Regulatory Artificial intelligence Digital health SAMD FDA

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