December 7, 2017
FDA issues guidance on 3D printing of medical devices
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.
Once considered a futuristic technology on the distant horizon, 3D printing of medical devices, medications and human tissue is quickly becoming a promising reality. Patients have already benefitted from 3D printed medical products through access to personalized devices and innovative drugs that have led to significant health improvements.
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