Analysis of the US FDA’s draft guidance on nitinol-containing medical devices

February 07, 2020

Senior Regulatory Consultant, Dr. Om Singh, was published in the February 2020 issue of the Journal of Medical Device Regulation.

An analysis of the US FDA’s draft guidance on nitinol-containing medical devices, and the reasons for its development

The unique properties of pseudoelasticity and shape memory behaviour make nitinol a popular choice of material in the medical device industry, especially in cardiovascular devices and surgical instruments. However, new evidence suggests that nitinol corrosion in vivo may affect the safety and performance of devices by adversely impacting their mechanical properties and/or biocompatibility. In addition, the thermo-mechanical behaviour and processing sensitivity of nitinol-containing devices has raised additional questions about safety and effectiveness. Based on scientific developments, the Food and Drug Administration (FDA) has released a new draft guidance document to outline the Agency’s technical recommendations for nitinol-containing medical devices, which is summarised in this article.

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