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
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