Health Data Management caught wind of guidance recently released by the FDA in regard to the future of the 3D printing industry.
This guidance was mostly aimed at the manufacturers of 3D printed devices. As Health Data Management was quick to point out, “[3D printing] is increasingly being used by radiologists and other medical professionals, typically to build accurate anatomical models that prepare clinicians and patients for surgery. However, there are growing indications that the technology will eventually come into play not only in radiological procedures but also in treating patients.”
FDA Commissioner Scott Gottlieb, MD, explained the reasoning behind the recent release of his agency’s guidance: “the FDA is now preparing for a significant wave of new technologies that are nearly certain to transform medical practice. We’re working to provide a more comprehensive regulatory pathway that keeps pace with those advances, and helps facilitate efficient access to safe and effective innovations that are based on thee technologies.”
In order to guide 3D printed device manufacturers in a productive manner, the FDA “reviewed more than 100 3D printer-manufactured devices currently on the market and has approved the first drug made on a 3D printer.”
Gottlieb continues: “we envision burn patients in the near future will be treated with their own new skin cells 3D printed directly onto their burn wounds. Further down the road, there is potential for the same technology to eventually be used to develop replacement organs.”
The FDA’s new 3D printing guidance “is intended to advise device manufacturers on the technical aspects of 3D printing, as well as what information they should include on submissions for developing 3D printed medical devices. This guidance includes FDA thinking on approaches to 3D printing such as device design, functional testing of products, durability of products, and quality system requirements.”
Image Courtesy of the FDA
Quotes Courtesy of Health Data Management