Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol
Submit Comments by 06/18/2019
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.
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All written comments should be identified with this document's docket number: FDA-2019-D-1470
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Guidance Issuing OfficeCenter for Devices and Radiological Health
Nitinol is a commonly used material in the medical device industry. Device manufacturers have used nitinol’s unique properties (i.e., pseudoelasticity and shape memory behavior) to design innovative medical devices that would not be possible with conventional materials. Nitinol has been extensively used in cardiovascular devices such as stents, heart valves, guidewires, and vena cava filters. The use of nitinol in other device areas is growing, particularly for products intended for use in minimally invasive procedures. The thermomechanical behavior and processing sensitivity of nitinol raise special considerations when compared to conventional metals such as stainless steel, titanium, or cobalt-chrome alloys. Due to the unique properties of nitinol, the Agency has developed this draft guidance to provide FDA’s current thinking on technical considerations specific to devices using nitinol. These recommendations are intended to be general and not product-specific and should be evaluated in conjunction with the intended use and technological characteristics of your device and any relevant device-specific guidances. The purpose of this draft guidance is to outline technical considerations associated with medical devices that have at least one patient contacting component comprised of nitinol.