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3D printed medical devices: a tough trial for regulation?

3D printed medical devices: a tough trial for regulation?

Written by Paul

October 23, 2018

3D printed custom-made prosthetic hand. Credit: Pixabay. he use of 3D printing in the medical industry is revolutionary and has huge potential. However, it also causes many issues for regulating bodies. Credit: Shutterstock. 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. Matthew Jacobson, an attorney in Reed Smith LLP’s Life Sciences Health Industry Group and member of the firm’s 3D printing Task Force, explains: “when products are manufactured in a warehouse, it is easy for regulators to regulate that warehouse and that manufacturer.” “These things [3D printed devices] could be printed on any possible location. So how would the FDA know where all these 3D printers are? Know who is printing everything and then be able to, if they wanted to, go to those facilities and make sure […]

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