On Aug. 6, 2025, the U.S. Food and Drug Administration (FDA) set forth its position on “PFAS (per- and polyfluoroalkyl substances) in Medical Devices” [PFAS in Medical Devices | FDA]. Ultimately, the FDA concludes that, based on its evaluation, “currently there is no reason to restrict [PFAS] continued use in devices,” and discusses the important distinction between small and large molecule fluoropolymers, emphasizing that large molecule fluoropolymers used in medical devices “have been safely used for decades.” The FDA also recognizes the unique properties of fluoropolymers in medical device applications and notes that currently no materials exist that can perform these critical applications. Read more.
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