Printing for Medicine: An FDA Framework for 3-D Printing for Medical Devices

Additive Manufacturing (AM), commonly known as 3-D printing, is increasingly being used in the manufacture of medical devices, including orthopedic and cranial implants, surgical instruments, dental restorations, prosthetics, and physical anatomical models for surgical planning. As of December 2015, more than 85 AM devices had been cleared by the Federal Food and Drug Administration. The 3-D printing market is forecasted to exceed US$21 billion by 2020.

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