FDA Issues Draft Guidance on Additive Manufactured Devices


FDA recently published draft guidance on technical considerations for additive manufactured devices in response to the technology’s advancements and investments. Orthopaedic device companies and suppliers are among those in the medical device community leading the technology’s adoption, and in so doing, driving the conversation with FDA. Therefore, companies that have explored the use of additive manufacturing should not be surprised by the content in the draft guidance.

The guidance is organized into two areas: design and manufacturing considerations and device testing considerations. While industry often speaks of additive manufacturing as an emerging and innovative technology, FDA’s thoughts and recommendations on the use of additive are similar to other manufacturing processes. Post-processing, cleaning and sterilization, each of which are outlined in the draft guidance, are among FDA’s and industry’s top priorities in ensuring the safety and quality of additive manufactured devices. We present high points of the draft guidance based on conversations with orthopaedic device companies and FDA.

Design and Manufacturing Process Considerations

FDA points out that, like most medical devices, it expects additive manufactured devices to adhere to quality system and design control requirements. Due to the different combinations of processing steps involved in additive manufacturing, FDA asks that you clearly identify each step in the process from design to software workflow to build to post processing—all of the steps outlined in the design and manufacturing section of the guidance.

At RAPID, Matthew Di Prima, Ph.D., Materials Scientist at FDA and the draft’s lead author, highlighted the guidance’s subsections on software workflow, materials control and post-processing.




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Josh Sandberg

Josh Sandberg is the President and CEO of Ortho Spine Partners and sits on several company and industry related Boards. He also is the Creator and Editor of OrthoSpineNews.

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