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.

For now, FDA has determined that it will not seek to impose a blanket PFAS restriction for medical device applications, as seen in many regulatory and legislative PFAS bans. That said, other U.S. agencies at the federal and state levels continue to issue regulations that may impact operations and the supply chain. Uncertainty also remains as to how, if at all, the concept of essential use and the recognition of distinctions between fluoropolymers and non-polymers will be sorted out in other markets such as the European Union, where significant restrictions on the use of PFAS in medical devices have been proposed.

Finally, even where, as here, FDA sets forth its basis to draw the distinction and declines to pursue restrictions, PFAS, along with adverse publicity and ongoing litigation, will continue to present challenges that call for close monitoring.