Regulations and Guidelines Being Issued for 3D-Printed Medical Devices

Published by , November 6, 2018 2:11 pm

(MedicalDeviceNetwork) 3D printed medical devices pose a huge challenge for regulatory bodies because, unlike traditional manufacturing techniques, 3D printers can be owned and used by anyone, not just manufacturing companies. In 2016, the growing number of approved 3D printed devices encouraged the FDA to issue preliminary guidance to manufacturers using 3D printing. The guidelines focus on design and manufacturing considerations, as well as device testing concerns.
Guidelines written by national regulators have been accompanied by international organisations, such as the ISO and ASTM, starting to create consistent, global standards for 3D printing of medical devices.
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