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Thursday, 05/12/2016 7:38:28 AM

Thursday, May 12, 2016 7:38:28 AM

Post# of 3191
http://www.fdalawblog.net/fda_law_blog_hyman_phelps/

"On May 10, FDA issued the long-awaited draft guidance, “Technical Considerations for Additive Manufactured Devices.” In October 2014, FDA held a public workshop on AM devices, “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” Since then, this draft guidance topic appeared on FDA’s priority guidance list in 2015, but was removed without explanation in 2016, leaving some to wonder about its status. The draft guidance states that it intends to “outline considerations associated with [additive manufacturing (AM)] processes” and provide “recommendations for testing and characterization for devices that include at least one AM fabrication step.” AM is “a process that builds an object by iteratively building 2-dimensional (2D) layers and joining each to the layer below, allowing device manufacturers to rapidly alter designs without the need for retooling and to create complex devices built as a single piece.” AM is a category of manufacturing which encompasses “3D printing.”"[much more]

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