> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Medical Device Nitinol Assessment Guidance
- URL: https://www.fdaweb.com/medical-device-nitinol-assessment-guidance/
- Published: 2019-04-18T12:00:00.000Z
- Updated: 2026-09-15T01:21:18.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143902

FDA has published a draft guidance, *Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol*, to give the agency’s current thinking on technical considerations specific to devices using nitinol, a commonly used material in the medical device industry. The [document](https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM636178.pdf?ref=fdaweb.com) says that medical device manufacturers have used nitinol’s unique properties (pseudoelasticity and shape memory behavior) to design innovative medical devices that would not be possible with cononventional materials. It has been used extensively in cardiovascular devices such as stents, heart valves, guidewires, and vena cava filters. And, it says, use of nitinol in other device areas is growing, particularly for products intended for use in minimally invasive procedures.