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FDA Issues Guidance for Additive-Manufactured Medical Devices

The U.S. Food and Drug Administration (FDA) has issued a final version of another Guidance, this one addressing technical considerations for medical devices produced using additive manufacturing technologies.

Additive manufacturing (AM, also often referred to as 3-D printing) technologies are being more widely leveraged in the production of advanced technology devices, including medical devices. Issued in early December, the FDA’s Guidance on additive-manufactured medical devices is intended to outline technical considerations associated with AM processes, as well as provide recommendations for the testing and characterization of medical devices that include at least one additively-manufactured component or an additively-fabricated process.

The FDA characterizes this Guidance as a “leapfrog” guidance, one that allows the agency to share its initial thoughts and ideas about emerging technologies that may have public health implications. As always, Guidance documents are intended only to provide insight into the FDA’s current thinking on the topic, and do not establish legally-enforceable responsibilities.

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Read the text of the FDA’s Guidance detailing technical considerations for medical devices produced using additive manufacturing technologies.

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