08/15/2025

US FDA Says ‘No Reason to Restrict’ Fluoropolymers Used in Medical Devices

Chemical Watch | Bobby DeMuro | August 15, 2025

US FDA Says ‘No Reason to Restrict’ Fluoropolymers Used in Medical Devices

The US Food and Drug Administration (FDA) has defended the use of certain PFAS polymers in medical devices, saying there is "no reason to restrict" them in medical equipment.

In a guidance webpage published on 6 August, the FDA said there is a distinction between small-molecule PFAS linked to environmental contamination and large-molecule fluoropolymers used in medical devices.

The publication comes as multiple US jurisdictions explore prohibitions on the use of PFAS in products, with many debating potential exemptions for fluoropolymers.

The FDA told Chemical Watch News & Insight that the agency published the webpage to "establish a reliable source of information" on the topic.

The PFAS used in medical devices are well-researched and "current available scientific information does not raise concerns about their continued use", the agency said.

Fluoropolymers are inert, non-water-soluble PFAS that industry groups say are safer than other chemicals in the class and should be regulated differently from other PFAS.

However, studies have found that fluoropolymer production may still generate PFAS of concern. That has led some scientists to urge governments to limit their use.

Fluoropolymers in medical devices

On its new guidance webpage, the FDA said that while small-molecule PFAS have been linked to health concerns, PFAS used in medical devices "are different".

Fluoropolymers such as polytetrafluoroethylene (PTFE) do not break down in the body or degrade into harmful substances and are thus safe for continued use in medical devices, the agency said.

Fluoropolymers are too large to cross through cell membranes and are "very unlikely to cause toxicity to patients", according to the agency. At the same time, they are essential for device function and "have been safely used for decades".

The FDA also cited a 2021 review it conducted with the Emergency Care Research Institute (ECRI), which found "no conclusive evidence of patient health issues" associated with PTFE – commonly known by the brand name Teflon.

"No other materials exist that can perform the critical roles of fluoropolymers in these devices," the FDA said. "There is no reason to restrict their continued use."

Environmental group pushes back

But some stakeholders were more hesitant to greenlight the sub-class.

Arlene Blum, the executive director of the Green Science Policy Institute (GSPI), disputed the FDA's assertion that fluoropolymers are safe.

Blum said the sub-group's "lifecycle is problematic" because although they are large and inert, they are made from small-molecule PFAS and can degrade into harmful substances over time.

"Fluoropolymers should only be allowed in medical devices when no safer options exist and manufacturers are actively developing better alternatives," she said.

Broad focus on sub-group

On its guidance webpage, the FDA acknowledged that both PFAS in medical devices and fluoropolymers more broadly have been "a recent topic of public interest".

In July, articles in the medical journal Heart Rhythm urged lawmakers to take a nuanced approach in regulating PFAS specifically to retain fluoropolymers for use in medical devices.

Earlier this year, New Mexico lawmakers exempted fluoropolymers from its sweeping PFAS-in-products law, while Illinois legislators cut the sub-group out of its more limited prohibitions.

Meanwhile, other states such as Maine and Minnesota have exempted medical devices from their broad bans, as regulation of that sector falls under the FDA’s purview.