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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
Earlier this month, the U.S. Food and Drug Administration (FDA) issued its final guidance associated with recall-related notifications and warnings. The guidance, entitled Public Warning and Notification of Recalls Under 21...more
The U.S. Food and Drug Administration (FDA) has issued final Guidance regarding Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C. The document makes limited changes to the Draft Guidance that was...more