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3D-Printing Final Guidance Clarifies Manufacturing Practice Expectations

A year and a half after FDA issued a draft guidance to help makers of devices that rely on additive manufacturing, the agency has finalized the document in its bid to get ahead of the technology.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 finalized leap-frog guidance on technical considerations for 3D printing isn't a major change from the draft version, but it does clarify FDA's expectation for removing manufacturing material residue in additive manufacturing processes.

FDA issued the draft guidance in May 2016 as part of an effort to get ahead of the inevitable boom in additive manufacturing to support manufacturing of devices, make more personalized medical technology and create 3D models that surgeons can use to enhance procedures

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