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

Nitinol-containing medical devices – Read about the updated acceptance criteria

If your email program has trouble displaying this email, view as a webpage. FDA Updates Final Guidance on Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol Today, the U.S. Food and Drug Administration (FDA) updated the Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol final guidance to clarify acceptance criteria for nitinol transformation temperatures when evaluating nitinol psuedoelastic properties. The final guidance was previously issued on October 15, 2020. The guidance outlines technical recommendations about information industry should include in premarket submissions for medical devices containing nitinol. Read the Guidance Questions? If you have questions about this final guidance, contact the Division of Industry and Consumer Education.

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