US FDA Gives Its Two-Cents On Nickel-Titanium Alloys
Executive Summary
Nitinol, a nickel-titanium alloy ubiquitous in medical devices, is getting more scrutiny from US FDA in a recently released draft guidance. As safety concerns have arisen in the past few years over biocompatibility of certain materials in implanted products, the agency is asking device makers to provide additional information on nitinol in their device submissions.