Since their U.S. Senate confirmations, HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Martin Makary have focused significant attention on one of the administration’s key policy priorities: improving the safety of...more
On December 4, 2024, the U.S. Food and Drug Administration (“FDA”) released its final guidance for industry on predetermined change control plans (“PCCPs”) for devices that utilize artificial intelligence-enabled software...more
12/11/2024
/ Artificial Intelligence ,
Biden Administration ,
Digital Health ,
Executive Orders ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Labeling ,
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Medical Devices ,
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Software