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FDA Drafts Guidance for Medical Devices Containing Nitinol

The thermomechanical behavior and processing sensitivity of nitinol raise special considerations compared to conventional metals, FDA says in new draft guidance for medical devices containing the nickel-titanium alloy.

These technical considerations are part of a new draft guidance FDA released for medical devices containing nitinol.

In March, FDA called for the public, scientists, and industry stakeholders to help the agency determine the current state of the science, critical gaps in the existing science, and what approaches should be considered to further the agency's understanding of medical device materials in order to improve the safety of devices for patients. The move is part of FDA's efforts to modernize its regulatory programs.

Now the agency has released a new draft guidance focusing on medical devices containing the nickel-titanium alloy known as nitinol. As highlighted in the infographic above, the guidance proposes technical information that manufacturers should include in regulatory submissions for devices containing nitinol. For more information on each of these considerations, read the draft guidance here.

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