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Key Takeaways
The FDA's August update regarding the use of PFAS materials in medical devices is a notable affirmation of the importance and safety of the materials as federal, state, and international agencies continue to propose and implement PFAS regulations in a wide range of applications.
On August 6, 2025, the FDA updated its current guidance on the use of per- and polyfluoroalkyl substances ("PFAS") in medical devices. The FDA emphasized the long history of using PFAS materials in medical devices, such as polytetrafluoroethylene ("PTFE"), and recognized that the PFAS compounds used in medical devices are large molecules that cannot cross cell membranes. The FDA stated that "no other materials exist that can perform the critical roles of fluoropolymers in these devices."
For example, fluoropolymers provide electric insulation in pacemakers and lubrication in stents. They also provide biostability that allows medical devices to remain in the body without the risk of breaking down in the body. Fluoropolymers also play important roles in catheters, blood bags, vascular grafts, and guidewires.
Based on its continuing evaluation of these materials and a 2021 independent study conducted by ECRI—a Patient Safety Organization designated by the U.S. Department of Health and Human Services—the FDA determined that there is currently no reason to restrict the use of these materials in medical devices. ECRI collected data from over 1,800 health care provider organizations, reviewed over 1,750 peer-reviewed articles, and conducted real-world surveillance of its network of health care providers. Based on these sources, the ECRI review found no conclusive evidence of patient health issues associated with the use of PTFE.
Other regulatory bodies are considering restrictions on the use of PFAS in medical devices. The European Chemicals Agency ("ECHA") is currently considering regulations regarding the use of PFAS in medical devices, including the possibility of a ban for certain uses and a ban for other uses that would go into effect in twelve years. That extended period would provide manufacturers time to identify suitable substitutes, even as ECHA recognizes that the alternatives "do not cover the whole range of properties [and] hence do not have equivalent levels of functionality." ECHA is currently considering the proposals, as well as the use of PFAS in other business sectors, and expects to deliver its recommendation to the European Commission in 2026.
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