December 7, 2017

FDA issues guidance on 3D printing of medical devices

By: Judy Mathias

Editor’s Note

Food and Drug Administration (FDA) commissioner Scott Gottlieb, MD, issued a statement December 4 on the FDA’s final guidance on medical device additive manufacturing, also known as 3D printing.

The FDA has reviewed more than 100 devices currently on the market that were manufactured on 3D printers, including knee replacements and implants for facial reconstruction.

Gottlieb notes that the FDA is preparing for a significant wave of new technologies that could transform medical-surgical practice, and this guidance will help manufacturers bring their innovations to the market more efficiently.

The guidance, which was published December 5, finalizes the draft version from May 2016.




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