This category of work is described in the guidance as “Software Workflow.” Key elements include imaging, design manipulation software, and build preparation software. The specific design is exact in its design parameters with allowance for natural manufacturing variation. A general design has details that could change noticeably from patient to patient depending on the patient imaging process and what design tools are used to adapt the device to its recipient. In a specific design the design tools are not vital for approval because the output is a specific, resulting in a well-defined product that has been thoroughly tested and evaluated. There are many questions to be asked in the additive manufacturing case: How do we know the design details are appropriate? How do we know there are no errors or mistakes? These errors could come from imaging, design modification, and manufacturing preparation. How do we know we can meet the original design requirements? The design software needs to not only design the right product, but needs to include the checks to know we have executed the steps properly. In an extreme design condition could we have thinner walls than normal? How do we know an extreme process for finishing does not reduce the wall thickness even more, meaning our final product may not have the required strength to meet the end user requirements and customer needs?

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