FDA Tackles 3-D Printing Considerations In Draft Guidance
This article was originally published in The Gray Sheet
A draft guidance issued by FDA on additive manufacturing, or 3-D printing, of medical devices is meant to be a starting point for an industry that is growing exponentially. The document outlines recommendations on topics such as device design, software considerations and material testing requirements.
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A year and a half after FDA issued a draft guidance to help makers of devices that rely on additive manufacturing, the agency has finalized the document in its bid to get ahead of the technology. The final guidance makes minor clarifications, but for the most is identical to the draft.
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.
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.