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GUIDANCE DOCUMENT

Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol Guidance for Industry and Food and Drug Administration Staff April 2019

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Docket Number:
FDA-2019-D-1261
Issued by:
Guidance Issuing Office
Center 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  Due to the unique properties of nitinol, the Agency has developed this draft guidance to provide FDA’s current thinking on technical considerations specific to devices using nitinol.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  The purpose of this draft guidance is to outline technical considerations associated with medical devices that have at least one patient contacting component comprised of nitinol.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2019-D-1261.