FDA Okays Continued PFAS Use in Medical Devices: Says Unlikely To Cause Harm

On August 6, 2025, the U.S. Food and Drug Administration (FDA) posted new information concerning the safety of fluoropolymers used in medical devices. Fluoropolymers, which belong to the PFAS class of substances (per- and polyfluoroalkyl substances), have long been used in medical devices, and FDA maintains its position that this use of PFAS is necessary in certain cases and unlikely to cause harm.

Safety of Fluoropolymers in Comparison to Other Types of PFAS

FDA stated that the PFAS used as components in medical devices are often large-molecule PFAS (polytetrafluoroethylene (PTFE) being the most well-known example), which differ from other PFAS often associated with potential environmental and health claims, which are typically small-molecule PFAS.

Furthermore, FDA cited the findings of a 2021 study conducted by FDA in a partnership with ECRI, a U.S. Department of Health and Human Services-designated Patient Safety Organization. The study reviewed peer-reviewed articles and used real-world clinical and healthcare surveillance networks and found no evidence of patient health issues associated with PTFE use in medical devices.

Consequently, FDA has concluded as to PFAS used in medical devices “that currently there is no reason to restrict their continued use.” Moreover, FDA notes that PFAS is essential to the safe and effective use of several devices and that no other materials currently exist that could replace the use of PFAS in these applications.

Safe Uses of Fluoropolymers in Medical Devices

FDA specifically highlighted the unique properties of fluoropolymers, which serve critical roles in medical devices. For example, fluoropolymers provide:

1. Lubrication for stents and other devices used in minimally invasive surgeries

2. Electronic insulation for pacemaker wires

3. Biostability, which allows devices to remain in the body for long periods of time

Key Takeaways

FDA continues to allow the use of fluoropolymers in medical devices, finding that their use is not associated with patient health issues. As such, FDA is not requiring any action by medical device manufacturers, though the agency continues to monitor the safety of PTFE and other PFAS used in medical devices.

Our team will continue to closely monitor and report on developments related to FDA’s approach to PFAS regulation and enforcement. Please reach out to any of us for further information.

© Arnold & Porter Kaye Scholer LLP 2025 All Rights Reserved. This Blog post is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.