3D-Printing Final Guidance Clarifies Manufacturing Practice Expectations
A year and a half after FDA issued a draft guidance to help makers of devices that rely on additive manufacturing, the agency has finalized the document in its bid to get ahead of the technology. The final guidance makes minor clarifications, but for the most is identical to the draft.
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Canada will test the feasibility of receiving structured regulatory information from medical device sponsors through its common electronic gateway. Separately, a draft guideline on 3D-printed devices is in the works and is expected to be issued for consultation later this year.
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.
3D printing has been hailed as a potentially game-changing technology for different industries. Biomedical applications, in particular, have garnered much attention when patients were able to receive 3D-printed, customized, lifesaving medical interventions. But aside from these niche markets for personalized medical devices, can 3D printing ever become mainstream in health care? This article, a guest column from leaders at the Boston Consulting Group, explores what the benefits of 3D-printed devices are and how they are driving the uptake of this technology. It also assesses how fast this adoption is happening and evaluates how – and in which biomedical applications and device markets – 3D printing could best enhance products and allow medtech manufacturers to grow their business.