FDA Declares PFAS Polymers in Medical Devices Safe and Currently Irreplaceable

See the update here.

The FDA explained that this position is supported by a 2021 independent safety review conducted by ECRI (formerly the Emergency Care Research Institute) in partnership with the FDA, which found no conclusive evidence of patient health issues associated with PTFE based on current scientific information and real-world surveillance of the health system. This is unsurprising, since fluoropolymers, unlike some small-molecule PFAS, are inert, non-toxic, and highly stable and cannot degrade into potentially toxic PFAS except under extreme conditions, such as pyrolysis. The FDA emphasized that fluoropolymers have a long history of safe use in critical medical devices, including cardiovascular stents, pacemakers, vascular grafts, and guidewires. They provide essential properties such as lubrication, electrical insulation, and biostability, and are unlikely to cause toxicity due to their molecular size. Currently there are no other materials capable of replacing fluoropolymers in these critical functions.

The FDA noted that it is continuing to monitor the safety of PFAS in medical devices and will update its guidance as new information becomes available.

At the state level, a growing number of laws target PFAS in consumer products but generally do not distinguish between fluoropolymers and other, non-polymeric PFAS. However, most currently enacted statutes specifically exempt medical devices regulated by the FDA. Notable state laws include:

• Colorado SB 24-081 (effective January 1, 2028): Prohibits certain products containing intentionally added PFAS, with explicit exceptions for drugs, medical devices, biologics, or diagnostics regulated by the FDA.

• Connecticut SB 292 (effective July 1, 2026): Prohibits or requires reporting of covered products with intentionally added PFAS, but exempts products governed by federal law or used in medical settings and regulated by the FDA.

• New Mexico HB 212 (effective January 1, 2028): Prohibits certain products with intentionally added PFAS, with exceptions for medical devices, drugs, and their packaging regulated by the FDA.

• Maine Public Law c. 477 (effective January 1, 2032): Prohibits certain products with intentionally added PFAS, exempting medical devices and drugs regulated by the FDA.

• Minnesota HF 2310/SF 2438 (effective January 1, 2032): Prohibits certain products with intentionally added PFAS, with exceptions for medical devices, drugs, and products governed by federal law. Notification requirements for products with intentionally added PFAS take effect January 1, 2026, with similar exemptions.

• Washington RCW 70A.350 and Draft Rule Chapter 173-337 WAC: Requires annual reporting for “priority consumer products” with intentionally added PFAS, which began on January 31, 2024, but excludes drug or biological products regulated by the FDA from being identified as priority consumer products.

To date, most state PFAS laws focus on specific consumer products such as juvenile products, textiles, ski wax, dental floss, and cleaning products and are not broadly written to include pharmaceutical products or medical devices. Where state laws do address PFAS in a manner that could impact medical products, they generally provide explicit exemptions for products regulated by the FDA, either per se or through federal preemption.

Stakeholders in the medical device industry should continue to monitor both federal and state regulatory developments regarding PFAS, but current evidence and enacted laws indicate that FDA-regulated medical devices containing fluoropolymers remain permissible under both federal and state regimes.

Our team will continue to monitor developments and provide updates as they become available. Please reach out to your ArentFox Schiff attorney contact or one of the authors with questions.