FDA In Brief: FDA outlines considerations on medical devices containing the metal alloy nitinol as part of ongoing efforts to evaluate materials in devices to address potential safety questions

FDA In Brief: FDA outlines considerations on medical devices containing the metal alloy nitinol as part of ongoing efforts to evaluate materials in devices to address potential safety questions

Today, the U.S. Food and Drug Administration published a draft guidance titled, “Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol,” which includes proposed recommendations on what manufacturers should include in their premarket submission of a device containing nitinol (an alloy of nickel and titanium), including testing to evaluate susceptibility to corrosion, biocompatibility and performance under certain conditions of stress/strain or temperature, and labeling — including language about the risk of potential allergic reactions to

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