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Per- and Polyfluoroalkyl Substances (PFAS) in Medical Devices
Given the public interest in PFAS (per- and polyfluoroalkyl substances) generally and their possible relationship to people’s health, the FDA is offering information about the PFAS used in medical devices. The PFAS used in medical devices are not the same as those identified as being potentially harmful to people in other contexts.
The PFAS materials currently used in medical devices have a long history of use, dating back to the 1950s. The FDA’s evaluation is that currently there is no reason to consider restricting their continued use in medical devices.
A new FDA web page may help you better understand why certain PFAS are used in medical devices.
Facts About PFAS and Medical Devices:
- The chemicals in medical devices have been safely used for decades and recent studies continue to support their safety.
- The FDA tracks and monitors the safety of PFAS in medical devices, including information received in an independent safety study.
- Not all PFAS are the same, and not all are toxic. Some perform essential functions in medical devices and there is currently no substitute for these critical materials.
Questions?
If you have questions about PFAS in medical devices, contact the Division of Industry and Consumer Education.
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