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Medical Devices / Regulatory Affairs / Research and Development

Q&A: CDRH Director Jeff Shuren on Leapfrog Guidances

Dec. 20, 2017

CDRH issued “leapfrog” guidance earlier this month on considerations for additive manufacturing, or 3D-printing, of medical technologies and other products.

CDRH Director Jeff Shuren said the agency is considering adding more details to the final guidance as it identifies novel technologies and there is insufficient guidance on what the agency’s recommendations would be on bringing the product to the market.

 “If we can’t work everything out, that’s fine. Let’s just put pen to paper on what we have worked out and maybe enter part of the puzzle,” he said. “That’s a lot better than not saying anything. Let’s not wait until we think we have all the answers.”

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