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Data Management Premarket Approval Applications

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

Knobbe Martens

FDA Issues Warning about Fraudulent and Unreliable Laboratory Data

Knobbe Martens on

The U.S. Food and Drug Administration (FDA) recently issued a Letter to Industry warning medical device manufacturers and device study sponsors (“device firms”) of a source of “fraudulent and unreliable laboratory testing...more

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