3D printing of medical products – FDA provides guidance to manufacturers

3D printing in healthcareDecember 4, 2017 – The U.S. Food and Drug Administration (FDA) on December 4 released a new set of recommendations for creating medical products using 3D printers. The guidance details the agency’s stance on device design, testing, and quality system requirements.

For a relatively new technology, 3D printing has a wide range of clinical applications, such as building functionally accurate replicas of complex anatomical structures and facilitating surgery simulations to restore hearing loss, remove stroke clots, and repair hip disorders. The rapid evolution of this technique has led the FDA to release an early policy framework to help manufacturers bring 3D-printed models to the market more efficiently.

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