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    Additive/3D Printing Manufacturing: Regulatory Concerns

    This article discusses “3D printing” or “additive manufacturing” for the manufacturing of medical devices, including replacement body parts. It draws much of its material from a new US FDA Guidance document that discusses the unique issues posed by this technology, key concerns due to radically different features of such manufacturing and various ways to address the resulting FDA quality and regulatory concerns relative to ultimate patient safety. Introduction The term ...