FDA Releases New Draft Guidance Document on 3D Printing of Medical Devices

Additive Manufacturing (AM), commonly known as 3D printing, is increasingly being used in the manufacture of medical devices, including orthopedic and cranial implants, surgical instruments, dental restorations, external prosthetics, and printing of physical anatomical models for surgical planning. In 2013, the market for 3D printing (products and services) was $3.07 billion. As of December 2015, more than 85 AM devices had been cleared by the U.S. Food and Drug Administration (FDA or the Agency). The 3D printing market is forecasted to exceed $21 billion by 2020.

In recognition of the rapid growth and advantages of using this technology, on May 10, 2016, FDA released a new draft guidance entitled, “Technical Considerations for Additive Manufactured Devices” (the “draft guidance”). The draft guidance builds on an earlier workshop2 held by the Agency and outlines the Agency’s initial thinking regarding the technical aspects of AM devices that should be considered for devices manufactured with at least one AM fabrication step. Relevant considerations extend to the development, production, process validation, and final testing of finished devices. The guidance focuses on devices, such as implants, produced using AM techniques.

The draft guidance is divided into two sections: Design and Manufacturing Considerations and Device Testing Considerations. Design and manufacturing considerations are intended to provide technical considerations for fulfilling quality system (QS) requirements for the finished device, while device testing considerations are intended to describe the type of information that should be submitted in premarket submissions for AM devices. It is important to note the Agency cautions that "point-of-care device manufacturing may raise additional technical considerations" not addressed in the current draft guidance.

A summary of the major points of the draft guidance is provided here.

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