FDA Allows PFAS in Medical Devices – Europe Plans Strict Restrictions
The U.S. Food and Drug Administration recently published a notice classifying certain per- and polyfluoroalkyl substances in medical devices as safe and indispensable. These chemicals, used in medical technology since the 1950s, differ from those variants that can pose health risks in other areas. The agency emphasizes that there is currently no reason to restrict their use, as studies and long-term experience support their safety. They serve essential functions in devices such as implants or catheters, where they ensure stability, low friction, and biocompatibility, without suitable alternatives being available. The agency continuously monitors new findings, including independent research, and has set up an information page to educate the public about the benefits and differences of these substances. This approach reflects a risk-based stance that prioritizes medical progress as long as no concrete dangers…


