Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol | FDA

Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol | FDA

FDA Issues Final Guidance on Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol

Today, the U.S. Food and Drug Administration (FDA) issued this final guidance: Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol.

Read the guidance

The final guidance:

• Describes recommendations about what information industry should include in premarket submissions for medical devices containing nitinol.
• Outlines technical recommendations including mechanical, corrosion, and biocompatibility testing.
• Provides consensus standard references and terminology to aid in the characterization of nitinol.

Questions?

If you have questions about this final guidance, contact the Division of Industry and Consumer Education.