FDA Confirms Continued Safe Use of Select PFAS in Medical Devices

On August 6^th, the U.S. Food and Drug Administration (FDA) reaffirmed that large-molecule fluoropolymers—classified as a subset of PFAS—can continue to be safely used in medical devices. These materials remain the standard for delivering critical properties, including lubrication, electrical insulation, biostability, and chemical resistance, with decades of documented safe clinical use. The FDA statement underscored that these fluoropolymers are “very unlikely to cause toxicity to patients”.  

This position is supported by an extensive FDA safety review conducted with ECRI, analyzing thousands of studies and real‑world data. The review found no evidence of patient harm from fluoropolymers such as PTFE and confirmed their unique performance benefits—lubrication, electrical insulation, and biostability—for which no suitable alternatives currently exist in critical medical applications.  

At Inhance Technologies, our proprietary fluorination process permanently modifies the surface of widely used plastics such as high-density polyethylene (HDPE) and ethylene propylene diene monomer (EPDM). This transformation forms a thin, stable, fluoropolymer-like layer that significantly enhances friction reduction, lubricity, and chemical resistance—performance attributes vital for many healthcare and other critical applications. Our solutions support safety and regulatory compliance while improving product performance and extending shelf life across a variety of sectors.

To learn how our Barrier and Surface technologies enable safe, high‑performance materials for your industry, click below or contact an Inhance Technologies expert today.