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New FDA Web Page Aims To Clarify Position On 3D Printing

As industry awaits more guidance and clarification from US FDA about its regulatory oversight of 3D-printed devices, the agency is attempting to be more transparent with a new web page that outlines some of its current thinking and efforts on the topic.

US FDA is attempting to be more transparent with regard to one of the most complicated and difficult topics in medical device regulations by launching a new page on its website that provides sponsors resources on its thinking on 3D printing.

On the site FDA notes 3D printing encompasses regulations from its drug, biologics and device centers, and provides links. The agency also clarifies that 3D printing includes the term "additive...

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