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The U.S. Food and Drug Administration has updated its webpage about PFAS (per- and polyfluoroalkyl substances) in medical devices to include new Frequently Asked Questions (FAQs) to help consumers understand what these materials are, why they are used, and how the FDA evaluates the safety and effectiveness of devices that contain these materials.
The webpage explains:
- Fluoropolymers used in medical devices differ from those identified as potentially presenting health concerns for people in other contexts
- Certain fluoropolymers are critical components of life-saving medical devices, including catheters, cardiovascular implants, and wound dressings
Questions?
If you have questions about this communication, contact CDRH’s Division of Industry and Consumer Education (DICE).
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