ARTICLE
11 August 2025

FDA Leads The Way On Fluoropolymers

AG
Akin Gump Strauss Hauer & Feld LLP

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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...
United States Food, Drugs, Healthcare, Life Sciences

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."

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