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FDA Tackles 3-D Printing Considerations In Draft Guidance

A draft guidance issued by FDA on additive manufacturing, or 3-D printing, of medical devices is meant to be a starting point for an industry that is growing exponentially. The document outlines recommendations on topics such as device design, software considerations and material testing requirements.

FDA has published a draft leapfrog guidance on 3-D printing that draws from a 2014 agency workshop on the topic. The guidance outlines key issues manufacturers should think about when designing products made with 3-D printers, including the materials used to make those devices and considerations when planning devices specific to individual patients.

Additive manufacturing, or 3-D printing, employs computer models to build three-dimensional objects by printing layers of materials – including plastics and polymers, metals, powders and liquids – on top of...

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