Washington, D.C., USA- January 13, 2020: FDA Sign at its headquarters in Washington DC. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.
August 6, 2025 — In light of increasing public concern regarding the health hazards associated with PFAS (per- and polyfluoroalkyl substances), the U.S. Food and Drug Administration (FDA) has made it clear that the PFAS types utilized in medical devices — particularly fluoropolymers — do not present a recognized risk to patient health.
Although there are thousands of PFAS compounds, the FDA pointed out that the specific materials employed in medical devices, like polytetrafluoroethylene (PTFE), are markedly different from the small-molecule PFAS compounds that are linked to environmental and health issues. For instance, PTFE has been safely utilized in both consumer and medical settings for many years, with its initial medical application tracing back to the 1950s.
PFAS represent a vast category of over 15,000 chemicals that are extensively used in numerous industries. Nevertheless, the FDA highlighted an important difference: while certain small-molecule PFAS compounds have been associated with health risks and detected in drinking water and soil, the fluoropolymers found in medical devices are composed of large molecules that do not readily penetrate cell membranes, rendering them unlikely to induce toxicity.
“These fluoropolymers are fundamentally different in structure and function from the PFAS compounds raising environmental concerns,” the agency said.
Critical to Modern Medicine
Fluoropolymers play an indispensable role in the functionality of many lifesaving and life-sustaining medical devices. These materials are essential for:
- Lubrication in stents and surgical delivery systems.
- Electrical insulation in devices like pacemakers.
- Biostability, allowing implants to remain safely in the body over long periods without degrading.
The FDA stressed that there are currently no alternative materials that match the unique properties of fluoropolymers for these purposes.
Independent Safety Review Finds No Evidence of Harm
In 2021, the FDA initiated an independent safety assessment conducted by ECRI, a non-profit recognized as a Patient Safety Organization by the U.S. Department of Health and Human Services. This review utilized data from over 1,800 healthcare provider organizations and more than 1,750 peer-reviewed scientific articles.
The result: no definitive evidence connecting PTFE or comparable fluoropolymers in medical devices to adverse health impacts on patients. The FDA reiterated its commitment to ongoing safety monitoring of all materials used in medical devices. “We will continue to evaluate the latest science and update the public as new information becomes available,” the agency stated.
For questions about fluoropolymer use in medical devices, the FDA encourages consumers and industry professionals to contact its Division of Industry and Consumer Education.
