US FDA Determines PFAS Fluoropolymers in Medical Devices are Safe

SG 125/25

Food and Drug Administration (FDA) review finds no conclusive evidence of patient care issues with polytetrafluoroethylene (PTFE) in medical devices.

On August 6, 2025, the FDA announced that the use of fluoropolymers, such as PTFE, in medical devices is safe and that there is no reason to restrict their continued use in these products.

These findings are based on a 2021 independent scientific study conducted by the agency in partnership with the Emergency Care Research Institute (ECRI), a US Department of Health and Human Services Patient Safety Organization. This comprehensive review found no conclusive evidence of patient care issues associated with PTFE in medical devices, drawing on data from more than 1,800 health care providers, over 1,750 published and peer reviewed scientific articles and ECRI’s real-world clinical and healthcare surveillance networks.

The FDA emphasized that fluoropolymers play a critical role in medical devices by providing lubrication, electrical insulation and biostability, and that there are currently no alternative materials with such unique and essential properties for device functionality.

The agency continues to monitor the safety of per- and polyfluoroalkyl substances (PFAS) and fluoropolymers in medical devices and will update its guidance as additional information becomes available.

We are committed to providing information about regulatory developments for consumer products as a complimentary service. Through our global network of experts and laboratories, we provide a wide range of services including physical/mechanical testing, analytical testing and consultancy work for technical and non-technical parameters applicable to a comprehensive range of consumer products. Contact us to learn more, or visit our website. In the end, it’s only trusted because it’s tested.