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FDA Releases Draft Guidance on Submission Recommendations for AI-Enabled Device Software Functions

On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” The draft guidance was long-anticipated; it...more

FDA Publishes Final Predetermined Change Control Plan Guidance for AI-Enabled Device Software Functions

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 “2024 Final...more

Predetermined Change Control Plans (PCCPs) for Medical Devices: FDA Issues Draft Guidance

On August 22, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled, Predetermined Change Control Plans for Medical Devices. The draft guidance describes how FDA plans to implement new...more

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