US FDA Ruling Confirms PFAS Fluoropolymers in Medical Devices Are Safe
GENEVA, SWITZERLAND / AGILITYPR.NEWS / September 04, 2025 / SGS, the world’s leading testing, inspection and certification company, has published SafeGuardS 125.25, reporting on the US Food and Drug Administration’s (FDA) review of per- and polyfluoroalkyl substances (PFAS) fluoropolymers in medical devices. The FDA has announced the results of a review finding no conclusive evidence of patient care issues with polytetrafluoroethylene (PTFE) in medical devices.
PTFE is a type of PFAS, a family of chemicals whose harmful effects on human health and the environment have led to restrictions on its use. PTFE is used for its non-stick, heat-resistant and chemical-resistant properties in many consumer products.
The announcement was made on August 6, 2025, with the FDA stating that there is no reason to restrict the continued use of PFAS fluoropolymers in products. Findings were based on the FDA’s 2021 independent scientific study conducted in partnership with the Emergency Care Research Institute (ECRI), a US Department of Health and Human Services Patient Safety organization.
The agency will continue to monitor PFAS safety for medical devices and update guidance where applicable.
SGS experts publish SafeGuardS to keep stakeholders informed about regulatory changes that could impact their business. SafeGuardS 125.25 includes further information on the ruling.
Stakeholders are encouraged to refer to the original SafeGuardS 125.25 for more details.
SGS medical device services
From syringes to pacemakers, medical devices must meet market-specific quality, safety and performance standards. SGS helps medical device manufacturers bring to market safe, high-performing products with a wide range of standard and non-standard tests and certification services. In the end, it’s only trusted because it’s tested. Learn more about SGS’s medical device services.
SGS SafeGuardS keep you up to date with the latest news and developments in the consumer goods industry. Read the full US FDA Determines PFAS Fluoropolymers in Medical Devices are Safe SafeGuardS.
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