How will future restrictions on PFAS in medical devices look? Current regulatory activities from the FDA and the EU REACH
10 September 2025
On 6 August, the FDA (U.S. Food and Drug Administration) published a letter regarding the use of per- and polyfluoroalkyl substances (PFAS) in medical devices, a topic that is currently being discussed by many countries and by regulatory bodies.
PFAS have garnered significant public attention due to concerns about their potential impact on human health and/or the environment. PFAS encompass more than 15,000 chemicals, differing considerably in their properties and uses. While certain small-molecule PFAS have been associated with potential health risks and may be found in environmental media such as drinking water, the PFAS in medical devices are typically large-molecule materials known as fluoropolymers.
Polytetrafluoroethylene (PTFE), a well-known fluoropolymer first incorporated into medical devices in the 1950s, exemplifies a large-molecule material. Fluoropolymers provide crucial functions such as lubrication in cardiovascular stents and minimally invasive surgical devices, electrical insulation in pacemaker wires, and biostability that supports longevity without degradation. These properties are vital for the effective and safe operation of medical devices, with fluoropolymers posing minimal toxicity risk due to their large molecular size, which cannot permeate cell membranes.
FDA’s Safety Assessment
The FDA continuously monitors the safety of fluoropolymers in medical devices. Partnering with ECRI (ERCI is an independent healthcare research nonprofit organization) for an independent safety review, the FDA utilized data collected from over 1,800 health care provider organizations and examined more than 1,750 scientific articles. The ECRI’s 2021 review found no substantial evidence of health issues associated with PTFE as a material used in medical devices.
The FDA remains vigilant, updating public information as new data emerge to support continued patient safety. In summary, while PFAS are a varied chemical family, those used in medical devices are distinct and have a proven track record of safety and critical functionality in health care applications.
EU REACH Safety Assessment
The European Chemicals Agency (ECHA) has published an updated proposal to restrict per- and polyfluoroalkyl substances (PFAS) under the EU’s REACH chemicals regulation. This update was prepared by the authorities in Denmark, Germany, the Netherlands, Norway and Sweden, who originally submitted the proposal in January 2023.
On 20th August 2025, five authorities, acting as the dossier submitter, have now finished evaluating the over 5,600 scientific and technical comments that were submitted by third parties during the 2023 consultation period. Based on the evidence gathered, they have updated their initial restriction proposal. This updated report, known as the Background Document, will inform the opinions of ECHA’s committees. This document may still be updated based on the committees’ evaluation. Among other things, the five authorities have identified and carried out assessments for eight sectors including medical applications.
Our experts and toxicologists are available to answer further questions you may have about PFAS, their potential availability in the future, possible toxicological risks in regard to medical devices and the market specific requirements or derogation provided by the FDA or REACH. If you would like to find out how we can help you overcome PFAS challenges, please visit our dedicated website.
