Devices

Technical Considerations for Devices with Nitinol

FDA has published a guidance, Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol, with the agency’s current thinking on technical considerations specific to devices using nitinol due to its unique properties. The document says nitinol is commonly used in the medical device industry.

Device manufacturers have used nitinol’s unique properties such as pseudoelasticity and shape memory behavior to design innovative medical devices that would not be possible with conventional materials, FDA says. Nitinol has been used extensively in cardiovascular devices such as stents, heart valves, guidewires, and vena cava filters. And the use of nitinol in other device areas is growing, it says.

FDA says the guidance’s recommendations should be evaluated in conjunction with the intended use and technological characteristics of the device and any relevant device-specific guidances. “The purpose of this guidance is to outline technical considerations associated with medical devices that have at least one patient-contacting component comprised of nitinol,” the document says.

The guidance contains Introduction and Scope; Background; Definitions; Technical Recommendations on general information, mechanical testing, corrosion testing, nickel ion release, and galvanic corrosion; Biocompatibility; and Labeling-Warnings.

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