Neil Young once sang of adapting to a world ruled by data and digital minds in “Computer Age.” Today, that vision feels increasingly real as the Food and Drug Administration turns to artificial intelligence (“AI”) in the face...more
The Food and Drug Administration recently issued a Warning Letter concerning unauthorized modifications made to a previously cleared medical device (i.e., 510(k)). ...more
3/26/2025
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Draft Guidance ,
Enforcement Actions ,
FDA Warning Letters ,
Food and Drug Administration (FDA) ,
Healthcare ,
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Medical Devices ,
Public Health ,
Regulatory Requirements ,
Risk Management ,
Warning Letters