Printing for Medicine: An FDA Framework for 3-D Printing for Medical Devices

meplateAdditive Manufacturing (AM), commonly known as 3-D printing, is increasingly being used in the manufacture of medical devices, including orthopedic and cranial implants, surgical instruments, dental restorations, prosthetics, and physical anatomical models for surgical planning. As of December 2015, more than 85 AM devices had been cleared by the Federal Food and Drug Administration (FDA or the Agency).  The 3-D printing market is forecasted to exceed $21 billion by 2020.

In recognition of the rapid growth and advantages of AM, on May 10, 2016, FDA released a draft guidance entitled, “Technical Considerations for Additive Manufactured Devices.” The document, which builds on an earlier FDA workshop, outlines a basic framework for considering FDA regulatory obligations in light of the differences presented by AM technologies.


About Peter Coffaro 1149 Articles

A growth-driven and strategic executive, Peter Coffaro commands more than 20 years of progressive management success within the medical device industry. As a District Sales Manager for Stryker Orthopaedics, Peter was responsible for managing and directing a regional sales force to achieve sales and profit goals within the Rocky Mountain region. Previously, he was the Director of Sales & Marketing for Amp Orthopedics. In this role, Peter was responsible for planning, developing, and leading all sales and marketing initiatives. Peter is a former orthopedic distributor in the Pacific Northwest. He has also worked with DePuy Orthopaedics as well as Zimmer, and held positions in sales, sales training, and sales management. Peter has an extensive background in organizational development, business development, sales management, negotiating and P&L management. Peter holds a B.S. degree in Biology from Northern Illinois University.

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