On December 4, 2024, FDA finalized its guidance entitled “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions” ...
The Food and Drug Administration issued a much-anticipated update on Tuesday detailing how it plans to regulate changes to artificial intelligence-enabled medical devices after the agency has ...
PCCPs allow device manufacturers to implement preapproved modifications to their devices in lieu of obtaining separate authorizations for each significant change prior to implementation. A PCCP ...
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