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3-D Printed Medical Devices Coming Under FDA Scrutiny
September 3, 2013
1 Min Read
The growing prevalence of medical devices manufactured using 3-D printers is prompting FDA to consider how to evaluate this growing technology subsector, according to a Fox news report.FDA currently evaluates 3-D-printed devices the same way it evaluates medical devices made using conventional methods. However, because 3-D-printed devices are manufactured using nonconventional means, it may be necessary to subject them to additional or different forms of testing. To meet this need, two FDA laboratories are investigating how 3-D printing could affect future medical device manufacturing practices.The Functional Performance and Device Use Laboratory uses computer-modeling methods to determine how modifications to a medical device could impact its safety and performance in various patient populations. Understanding the effects of these modifications helps FDA to evaluate devices that are customized to an individual patient or group.The Laboratory for Solid Mechanics focuses on how different printing methods affect the strength and durability of the materials used to make medical devices. This lab's findings should enable FDA to develop standards and set parameters for scale, materials, and other critical features that contribute to medical device safety and innovation, according to a blog posted by FDA scientists.
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