Bottom Line
The FDA is making a strong effort to create a set of regulatory parameters which can corral the risks associated with 3D/additive manufacturing processes. The agency is asking for industry collaboration and, with this guidance document, has made excellent progress in identifying risks and possible solutions.
This is a work-in-progress, but it is moving in the right general direction.
And, the orthopedic community—broadly defined—needs this to work well.
