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Additive Manufacturing of Medical Devices: The FDA Perspective

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Conference Abstract: Additive Manufacturing (AM) is a blanket term for a suite of manufacturing technologies that use a digital format to build a part layer by layer. While this technology was developed in the early 80’s and commercialized later that decade, it saw little use in medical device production before 2000. From 2010 to 2020, FDA stood up a working group focused on AM, had significant stakeholder interactions, published a Guidance, and assumed leadership in AM standards development. As a result, the handful of 510(k) cleared devices utilizing AM technologies in 2010 jumped to over 350 by the year 2020. To work through this process, the medically relevant AM technologies will be discussed along with the perceived benefits of using AM for medical device production. Then, the kinds of 510(k) cleared devices and observed trends in those clearances will be presented from that decade along with the concurrent standards in development. The presentation will conclude with FDA’s activities across that decade to ensure AM device safety and effectiveness.