Podcast: US FDA's James Coburn Chats About 3D Printing
US FDA recently heard from range of stakeholders on the issue of 3D-printing anatomical models during a meeting at the agency's Maryland headquarters. James Coburn, a senior engineer at FDA's device center, spoke to Medtech Insight following the meeting about what he learned and next steps for this rapidly evolving technology.
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Although certainly not a given, many researchers and companies are pursing the eventual goal of bioprinting human organs, starting with the three-dimensional printing of a structure that has cellular function. If organ function via bioprinting becomes a reality for the skin, bone, lung, liver, eye and/or kidney, among other potential organs, the market opportunity could be in the billions. But challenges, including cost and ethics, stand in the way of this milestone in regenerative medicine.
Industry, health-care providers and FDA discussed major issues in using additive manufacturing for making anatomical models at the agency's headquarters last month. The findings will be presented in a white paper from the Radiological Society of North America to help FDA figure out how to regulate the technology.
To mesh with a final order reclassifying medical-image analyzers, the US agency has also published a final guidance on computer-assisted detection (CADe) devices that was first finalized more than six years ago.