• Radiologic Technology News

    FDA Offers New Guidance for Manufacturers of 3-D Printed Medical Products

    Dec 05, 2017

    After review of more than 100 devices currently on the market, the U.S. Food and Drug Administration has issued a comprehensive policy framework to manufacturers creating medical products on 3-D printers. Some examples of 3-D products used today include knee replacements and skull implants designed for facial reconstruction.

    An announcement issued by the FDA alongside their guidance recommendations said, “We envision that burn patients in the near future will be treated with their own new skin cells that are 3-D printed directly onto their burn wounds. Further down the road, there is the potential for this same technology to eventually be used to develop replacement organs.”

    Called “leap-frog” guidance because it helps bridge current technology with the next generation of innovation, the recommendations are intended to provide the FDA’s initial thoughts on an emerging technology. The guidance is voluntary, not mandatory at this time.

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