FDA issues new guidance on 3D printing medical devices

The U.S. Food and Drug Administration (FDA) issued a new guidance Monday detailing the agency’s initial thoughts and recommendations related to the 3D printing of medical devices.

“Patients have already benefitted from 3D-printed medical products through access to personalized devices and innovative drugs that have led to significant health improvements,” FDA Commissioner Scott Gottlieb, MD, said in an official statement. “But 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 these technologies.”

Gottlieb noted that the FDA has already reviewed more than 100 medical devices manufactured on 3D printers, calling it “likely just the tip of the iceberg.”

“We envision that burn patients in the near future will be treated with their own new skin cells that are 3D printed directly onto their burn wounds,” he said. “Further down the road, there is the potential for this same technology to eventually be used to develop replacement organs.”

The guidance includes information on how to properly submit devices to the FDA, device design, how to test for function and durability and much more. Gottlieb notes that this is a “leap-frog guidance,” meaning that these recommendations will likely change rather quickly as the technology continues to evolve.

The full 31-page guidance can be read on the FDA’s website.