FDA Moves Forward on Fluoropolymers

On August 6, 2025, the U.S. Food and Drug Administration (FDA) became the latest governmental agency to confirm that fluoropolymers are both safe and necessary. After an independent safety review of fluoropolymers in medical devices showed no conclusive evidence of health issues, FDA concluded that fluoropolymers are “very unlikely to cause toxicity” because of molecular size and further that they are essential for medical devices to function. As a result, “FDA’s evaluation is that currently there is no reason to restrict their continued use in devices.” This announcement will be a source of relief to the device and diagnostics industries.