Per- and polyfluoroalkyl substances (PFAS) are a group of more than 10,000 different fluorine-based synthetic chemical compounds used in a wide variety of products, including food packaging, cosmetics, personal care products, and textiles. In medical manufacturing, PFAS-based fluoropolymers such as polytetrafluorethylene (PTFE) have been essential in devices and components like guidewires, catheters, and pacemaker leads because they are biocompatible and able to withstand high temperatures and chemical exposure.
More recently, however, governments worldwide have begun to tighten regulations regarding the use of PFAS materials, some even banning them entirely, due to environmental and health concerns. These changes are forcing medical device manufacturers to act quickly to adapt to new regulations and become compliant before PFAS restriction deadlines arrive.
Keep reading to learn more about these regulations, including impending deadlines and how silicone tubing provides an effective alternative to PFAS in medical devices.
Why Is PFAS Use Being Restricted?
While PFAS compounds have been used for decades in medical devices due to their durability and resistance to sterilization procedures, they have begun to cause concern because they linger in the environment for long periods of time. Dubbed “forever chemicals,” PFAS can be found in groundwater for years and tend to bioaccumulate in humans, potentially leading to health complications such as liver toxicity.
Due to the potential health risks posed by these chemicals, and the still limited understanding the scientific community currently has about the long-term harm they could cause, the US Environmental Protection Agency (EPA) has released health advisory statements for multiple PFAS chemicals, and Europe has restricted certain PFAS compounds under EU REACH regulations.
The Global PFAS Regulatory Landscape
As concern grows over the potential long-term health and environmental threats posed by PFAS compounds, governments around the globe have begun to enact regulations restricting their use. This has a profound effect on numerous industries, but especially the medical device industry, as manufacturers will have to adjust product designs and specifications, as well as find new suppliers for raw materials to replace PFAS-based components.
Some of the most important regulations to date include:
US Federal Regulations
To combat the effects of PFAS compounds, the EPA enacted the Significant New Use Rule (SNUR) in 2024, requiring companies to notify the EPA before manufacturing or processing 329 inactive PFAS compounds, triggering a risk assessment. Additionally, PFAS will now be listed under the Toxics Release Inventory (TRI), requiring supplier notification upon first shipment. Reporting will be due by July 1, 2026, and a total of 205 PFAS compounds are included. Additionally, TSCA Section 8(a)(7) reporting requires manufacturers and importers to report PFAS use dating back to 2011, with data due by January 11, 2026 (small manufacturers have until July 11, 2026).
Some US states, including Maine, Minnesota, Colorado, Washington, New Mexico, New York, Maryland, and California also have state-level restrictions or reporting requirements in place for some or all uses of PFAS materials.
European Union Restriction Proposal
In addition to the PFAS compounds already restricted under the EU’s REACH regulations, the European Commission is reviewing more than 10,000 PFAS compounds to determine which will be restricted from being manufactured, sold, or used above certain concentration limits. A decision on these regulations is expected in the coming months.
In contrast to the broad scope of the EU’s restrictions, the UK is taking a more piecemeal approach, and will release plans for reviewing and restricting PFAS chemicals in different applications in 2026.
International PFAS Restrictions
Several countries outside the US and EU have also started placing restrictions on PFAS chemical use in various industries. New developments appear frequently, and it’s important to monitor these as they expand to additional countries, products, and use cases.
- Japan. Starting in 2024, Japan began banning PFHcS, PFOA, and related PFAS compounds under its Chemical Substances Control Law (CSCL).
- Canada. As of 2025, PFAS chemicals have been banned in firefighting foams and bans on non-essential uses in cosmetics, food packaging, textiles, paints, cleaning products, and ski waxes are planned for the near future.
- New Zealand. PFAS chemicals in cosmetics will be banned starting in 2027.
- Australia. PFOS, PFOA, PFHxS, and related compounds are prohibited, and importers and manufacturers must track and report PFAS volumes and uses. However, medical devices are currently exempt from these bans.
- Taiwan. Maximum allowable PFAS limits in drinking water will be enforced by July 2027.
The Impact on Medical Device (and Other) Manufacturers
Many medical devices and their component parts will be impacted by these restrictions, and manufacturers must adapt their products and find alternative chemicals and materials quickly. It is critical to find comparable, biocompatible materials with similar resistance profiles as PFAS materials so that device safety and efficacy are not compromised.
Silicone Tubing Alternatives
One example is medical tubing, which frequently incorporates PFAS chemicals. Silicone tubing is becoming a popular, safer option, in particular, specialized USP-VI (6) grades, which are a leading replacement for non-invasive essential components.
Medical-grade silicone is a suitable choice because it is chemically inert, hydrophobic, and offers biocompatibility and high mechanical properties like PFAS. This makes silicone a versatile alternative to PFAS with wide-reaching applications in the medical device industry.
Reporting Compliance Deadlines
In the US there are several reporting deadlines to be aware of for 2026 and 2027:
- April 13, 2026: PFAS reporting begins under the Toxic Substances Control Act (TSCA).
- October 13, 2026: Final deadline for most manufacturers and importers to submit PFAS data to the EPA.
- April 13, 2027: Final deadline for small businesses that import PFAS in articles. A small business is defined as one with under $120,000,000 annual sales by its parent company or under $12,000,000 sales. An “article” refers to an imported item that contains PFAS chemicals, and does not refer to articles the small business manufactures itself with PFAS chemicals or raw PFAS materials it imports.
Transition to PFAS-Free Materials with Help From Vanguard Products Corporation
Tightening regulations regarding the use of PFAS compounds can present challenges for medical device manufacturers, such as supply chain disruptions. It is essential to partner with a trusted supplier to navigate the changes and to obtain safer alternatives to PFAS products and materials.
With over fifty years of history in the silicones and specialty elastomers arena, Vanguard Products Corporation can provide specialty, silicone tubing and profiles for PFAS replacement reliably and with fast turn-around times. Contact us today to learn more about our products and to request a quote.