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FDA Publishes Draft Guidance on 3D Printing of Medical Devices

The U.S. Food and Drug Administration (FDA) recently published draft guidance regarding the 3D printing of drugs and medical devices. The guidance is long overdue, as the agency has already cleared more than 80 medical devices that used 3D printing along with one prescription drug.

3D printers now make it possible to create a new object by downloading a design file and hitting “print.” The technology is increasingly being used in the pharmaceutical and medical device industries, particularly to develop personalized drugs, prosthetics, and other medical products.

While 3D technology holds great promise, it also poses regulatory challenges. To date, all FDA approvals have been issued through traditional pathways. However, 3D printed medications and devices pose a range of unique safety concerns.

To address 3D printing issues, the FDA recently issued a draft guidance for Technical Considerations for Additive Manufactured Devices. According to the agency, the draft guidance is a “leap-frog” guidance, which means it is intended to serve as a mechanism by which the FDA can share initial thoughts regarding the emerging technology. As highlighted by the FDA, the guidance “represents the Agency's initial thinking, and our recommendations may change as more information becomes available.”

The FDA guidance specifically addresses the technical considerations associated with 3D printing and makes recommendations for design, manufacturing, and testing of medical devices that include at least one fabrication step using “additive manufacturing.” The term refers to a process that builds an object by iteratively building 2-dimensional (2D) layers and joining each to the layer below.

The FDA guidance is divided into two parts. The first section of the guidance addresses design and manufacturing considerations. It specifically provides technical considerations that should be addressed as part of fulfilling Quality System requirements for manufacturing a device, as determined by its regulatory classification or regulation to which it is subject. The second section covers device testing considerations. It describes the type of information that should be provided in premarket notification submissions [510(k)], premarket approval (PMA) applications, and other applications for a 3D printed device.

As San Diego product liability attorneys, we will be closely tracking the FDA’s efforts in the area of 3D printing. We are hopeful that the new technology can revolutionize the way medical devices are made without compromising patient safety.

If you or someone you care about has suffered serious harm due to a dangerous or defective drug or medical device, don’t hesitate to contact a San Diego injury lawyer at the Law Offices of Robert Vaage for a free consultation. Our legal team has successfully represented clients against manufacturers and distributors of medical devices for more than 30 years.