FDA issues draft guidance expanding recommendations on medical devices containing nitinol

Today, the U.S. Food and Drug Administration (FDA) issued the draft guidance: Technical Considerations for Non-Clinical Assessment of Medical Devices containing Nitinol. The use of nitinol, a nickel-titanium alloy commonly used in a diverse range of medical devices, has increased over the past two decades – particularly for cardiovascular stents, guidewires and other devices used in minimally-invasive medical procedures.

To ensure that benefits patients receive from nitinol-containing devices outweigh any risks resulting from their use, the FDA needs to receive the right information as part of the premarket review process. To that end, this draft guidance provides manufacturers with proposed recommendations about the type of information to include in their premarket submissions of devices containing nitinol.

Ensuring that medical products available to patients are safe and effective is central to the FDA’s mission. Today’s draft guidance is part of our ongoing effort to evaluate materials in medical devices to address potential safety issues. Please note, this draft guidance is not final nor is it in effect at this time.

Read the Guidance