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FDA and 3D Printing of Medical Devices: Past, Present and Future

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In 2020 3D printing, or additive manufacturing, is strongly linked to medical device manufacturing but this has not always been the case.  This presentation will discuss the initial use of 3D printing of medical devices and the FDA’s early efforts, including a summary of the 2014 workshop “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing”; the 2017 guidance “Technical Considerations for Additive Manufactured Medical Devices”; and the main findings of the 2018 paper “Regulating 3D-Printed Medical Products.” The improvement in regulatory knowledge, industry adoption, and capabilities of the technology will be touched upon as these past activities are summarized and how those trends have led to present-day efforts.  These present-day efforts include the FDA’s current outreach to stakeholders to develop a policy regarding 3D printing of medical devices at the point of care, research into the effect of design and build parameters on the performance of lattice structures, and the use of optimized topology as a medical device design tool.  Looking to the future, the FDA is preparing for new innovations in 3D printing and other advanced manufacturing technologies through engagement with several standard bodies, professional societies, and public-private partnerships.  Not only will this allow the FDA to ensure safe and innovative products are available to the American public, but these activities allow the FDA to engage with stakeholders in pre-competitive spaces to ensure regulatory issues can be addressed earlier in the technology development process.