PFAS in Medical Devices: What’s New and What to Do

For medical device companies, the PFAS landscape is becoming more defined, but not necessarily simpler. FDA has clarified its position on fluoropolymers used in devices, states are moving ahead with broader PFAS definitions and new reporting and disclosure requirements, and the EU continues to advance a much more robust restriction framework.

At the same time, PFAS risk is expanding beyond the question of whether a particular material can still be used. Manufacturers also need to think about reporting obligations, manufacturing and waste streams, supplier exposure and the potential impact on development and commercialization. In 2026, the challenge is less about reacting to a single rule and more about understanding where PFAS creates risk across the product lifecycle.

The PFAS Environment in 2026: More Clarity, More Complexity

For medical device companies, the PFAS picture is becoming clearer, but not necessarily simpler. Regulators are beginning to differentiate among PFAS chemistries and uses, while states and international markets continue to move in different directions. The result is a landscape that requires more precise decisions about where PFAS are used, what obligations apply and where future risk may emerge.

• FDA has drawn a much clearer line around fluoropolymers in medical devices. In a September 2026 update, FDA emphasized that the large-molecule fluoropolymers used in many devices are different from the smaller PFAS associated with environmental contamination and many health concerns. The agency says it is not aware of evidence showing harmful public-health effects from fluoropolymer PFAS in medical devices and sees no reason to restrict their continued use. That provides important reassurance for materials such as PTFE and ePTFE used in catheters, implants, guidewires and other devices. But it does not remove PFAS from the broader compliance picture: non-polymer PFAS associated with manufacturing inputs, residuals or waste streams may still be subject to separate environmental requirements.

• State requirements are creating a more fragmented compliance picture. Minnesota’s Amara’s Law shows why an exemption from a product ban does not necessarily mean a manufacturer is exempt from PFAS obligations. Manufacturers of covered products containing intentionally added PFAS were required to submit initial reports by September 15, 2026. Other states are developing their own disclosure, reporting and product restrictions, leaving manufacturers to navigate requirements that may differ substantially from one market to another.

• The international picture remains less settled. In Europe, the proposed universal PFAS restriction under REACH continues to move through the regulatory process. ECHA’s Risk Assessment Committee adopted its opinion in March 2026, while the Socio-Economic Analysis Committee advanced its assessment of the costs, benefits and availability of alternatives. ECHA has signaled support for a broad restriction with targeted derogations rather than a single undifferentiated ban. However, even derogated uses may cause substantial obligations. For medical device manufacturers, that means future treatment of particular uses, transition periods and exemptions still matters greatly. A material acceptable in the U.S. may eventually face a different pathway in Europe.

• Commercial and supply-chain pressures are developing alongside regulation. PFAS questions are increasingly surfacing in investor and partner due diligence, customer discussions and supplier documentation. At the same time, changes in the fluoropolymer supply base can affect availability even when a material remains technically acceptable and legally permissible.

Taken together, these developments are shifting PFAS from a largely speculative future concern toward a more immediate planning issue. For manufacturers, the question is therefore no longer simply, Can we use this material? It is also whether its use can be documented and defended, whether the supply will remain reliable and whether the same product strategy will work across the markets the company intends to serve.

What Medical Device Teams Can Do Now

The goal is not to eliminate PFAS indiscriminately. It is to understand where PFAS create meaningful regulatory, technical or business risk and address those risks before they become expensive problems. That requires looking across the full product lifecycle, not just at the materials listed in the device BOM.

• Build a complete picture of where PFAS are used and where they may leave the system. Start with the finished device, but extend the review to coatings, supplier components, processing aids, manufacturing equipment, packaging and other inputs. Manufacturing waste, wastewater and solid waste deserve particular attention because they may create environmental obligations that are separate from the rules governing PFAS in the device itself. The first step is visibility: knowing what is present, where it enters the lifecycle and where it may ultimately go.

• Map the regulatory requirements that actually apply. PFAS obligations can depend on the chemistry involved, where a product is sold or distributed, how the material is used and whether the issue involves the finished product, reporting or an environmental release. A regulatory applicability review can help separate requirements that demand action now from rules that simply need to be monitored. That distinction becomes especially important when a device is exempt from a restriction but still subject to reporting or disclosure.

• Prioritize PFAS uses based on function and risk. Not every PFAS-containing material warrants the same response. Some fluoropolymers may be central to device performance or patient safety, while other uses may be incidental or easier to replace. Understanding why the material is there helps teams decide where substitution is worth pursuing and where retaining a well-characterized material may be the more defensible choice.

• Evaluate alternatives before they become urgent. Where substitution makes sense, it should be treated as an engineering decision rather than a simple materials swap. Alternatives may need to be assessed for performance, biocompatibility, sterilization compatibility, manufacturability, durability and regulatory impact. Starting that work early preserves options and reduces the risk of a late-stage redesign.

• Strengthen documentation and supply-chain visibility. Companies should be able to explain where PFAS are used, why critical uses are necessary, what reporting obligations apply and what alternatives have been considered. That requires better information from suppliers as well as awareness of potential reformulations, market exits or availability changes that could affect critical components. The groundwork laid now can make it much easier to respond to future reporting requirements, investor questions or changes in market access.

Battelle can help connect those pieces. Its medical device, materials, analytical, environmental and regulatory teams can work together to identify PFAS across products and processes, assess regulatory applicability, characterize materials and waste streams and evaluate alternatives without losing sight of device performance or patient safety. That integrated perspective is especially valuable for PFAS because the right answer may involve a material change, better analytical data, stronger documentation, changes to a manufacturing process or simply a clearer understanding of why an existing material remains appropriate.

The objective is PFAS readiness: knowing where the risks are, addressing the ones that matter and maintaining enough flexibility to respond as regulations, suppliers and markets continue to change.

Ready to get ahead of PFAS risk? 

Talk with Battelle’s medical device and PFAS experts to understand where PFAS enter your product lifecycle, what requirements apply and where targeted action can reduce regulatory, supply-chain and commercialization risk.