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FDA Finalizes Additive Manufacturing Guidance

By Carolyn LaWell

FDA recently published its guidance on additive manufacturing technical considerations, outlining the Agency’s long-awaited position on use of the technology for medical devices.

Like you, we’ve eagerly awaited the finalization of this guidance. Few topics have dominated our conversations with device companies, suppliers and surgeons like additive has in recent years. FDA points out that the 31-page document is considered “leapfrog” guidance, a term reserved for FDA’s anticipation that its initial thoughts on an emerging technology will change over time. In short, more questions and answers will continue to arise as the technology is adopted.

What we do know is that FDA outlines its thoughts on the phases of design development, production process, process validation, semi-finished and final finished device testing.

While the full guidance, “Technical Considerations for Additive Manufactured Medical Devices,” can be read online, we’ve chosen to highlight three points related to questions with which readers have often approached us: device design, materials and cleaning/testing.

Read more at BONEZONE.