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Machine Learning Premarket Approval Applications Data Management

Foley & Lardner LLP

AI-Enabled Device Software Functions: FDA’s Final Guidance for Predetermined Change Control Plans

Foley & Lardner LLP on

On December 4, 2024, the U.S. Food & Drug Administration (FDA) released its Marketing Submissions for a Predetermined Change Control Plan (PCCP) for Artificial Intelligence-Enabled Device Software Functions (AI-DFS) final...more

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