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Regulatory Challenges Emerge for Additive Manufacturing

This piece was originally published in the August 2016 issue of electroindustry. Megan A. Hayes, Director, Regulatory and Standards Strategy, MITA Additive manufacturing (AM) is another term for the synthesis of three-dimensional objects—otherwise known as 3D printing. This concept is nothing new to the U.S. Food and Drug Administration (FDA), which already has approved or cleared more than 80 medical devices and one...

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