USA – CDRH Draft Guidance Tackles Nitinol Devices

As part of a broader effort to address potential safety issues from materials in medical devices, the US Food and Drug Administration (FDA) proposed technical considerations for nitinol-containing devices.

The draft guidance FDA’s Center for Devices and Radiological Health (CDRH) issued on Thursday covers the types of information to include in premarket submissions of devices made from nitinol, including material composition and manufacturing parameters, pseudoelasticity and nitinol transformation temperatures. Other recommendations relate to mechanical and corrosion testing methods, nitinol device biocompatibility assessments and labeling.

An uptick in use of nitinol in the past two decades underscored a need for clarifications. Growth in the use of the nickel-titanium alloy has been evident with stents, guidewires and other devices in minimally-invasive medical procedures. The draft guidance targets how the material breaks down inside the body.

“Devices made with nitinol provide many important benefits to patients, but we need to be able to assess whether, among other things, there are any health risks when the material comes into contact with various parts of the body for extended periods of time,” CDRH Director Jeff Shuren said. “To ensure that the benefits patients receive from these devices outweigh any risks resulting from their use, the FDA needs to receive the right information as part of the premarket review process.”…