On September 10, the Food and Drug Administration (FDA) Biocompatibility and Toxicology Program published a statement announcing its intention to commission an independent literature review and internal bench laboratory study...more
9/26/2024
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The latest efforts by the U.S. Food and Drug Administration (FDA) to modernize regulation of the 510(k) program come in the form of a trio of new draft guidance documents regarding its Premarket Notification program for...more