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‘The Sky’s The Limit’ For 3-D Printed Medical Devices, FDA Says

In an interview with “The Gray Sheet,” staff in CDRH’s Office of Science and Engineering Laboratories discuss the center’s research studies on 3-D printers used to manufacture medical devices and describe the challenges and opportunities that lie ahead.

The enthusiasm for three-dimensional printing that’s inspired everyone from lampshade crafters to aerospace engineers is hitting the medical device industry, too. The process, in which specialized printers print layers of polymers or other materials to create objects, is now being researched by engineers at CDRH’s Office of Science and Engineering Laboratories so FDA can be more prepared.

“The Gray Sheet” spoke with OSEL Director Steven Pollack, research engineer James Coburn and materials scientist Matthew Di Prima to get a primer on how 3-D printing of medical devices...

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