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US FDA Works To Finalize 3D Printing Guidance; Industry Asks For More

A top FDA device official says the agency is hoping to finalize an additive manufacturing guidance this year. Industry is particularly interested in seeing the leap-frog guidance made final, but would also like to see more clarification and a separate guidance to address the topic of patient-specific manufacturing.

US FDA is hoping to finalize a "leap-frog" guidance on 3D printing of medical devices this year, but industry groups want the agency put greater detail and attention on the issue of patient-specific devices in a standalone document on that topic.

Speaking to Medtech Insight at FDA's Science Forum on May 31, James Coburn, a senior engineer at the device center, emphasized the timeline goal for the guidance, which focuses on "technical considerations for additive manufactured devices

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