As 3D printing technology in the medical field continues to mature, the Food and Drug Administration is issuing extensive guidance to manufacturers of 3D devices.
The technology 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.
“The FDA is now preparing for a significant wave of new technologies that are nearly certain to transform medical practice,” says Scott Gottlieb, MD, who heads the federal agency. “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.”
The FDA has reviewed more than 100 3D printer-manufactured devices currently on the market and has approved the first drug made on a 3D printer. This drug, which dissolves more rapidly in the mouth to work faster, is used to treat seizures. And it foresees more potential uses for the printers in medical treatment.
“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,” according to Gottlieb. “Further down the road, there is potential for the same technology to eventually be used to develop replacement organs.”
The guidance, available here, is intended to advise device manufactures on the technical aspects of 3D printing, as well as what information they should include on submissions for developing 3D medical devices. Guidance includes FDA thinking on approaches to 3D printing such as device design, functional testing of products, durability of products and quality system requirements.
However, Gottlieb stresses that the guidance is only initial thoughts about the emerging technology and FDA recommendations could evolve in unexpected ways. The agency also anticipates creating regulations governing the use of 3D printing in medical facilities and academic institutions, such as a university laboratory.
FDA further will review regulations on the bioprinting of biological, cellular and tissue-based products to assess if more guidance is needed beyond a recently issued framework on regenerative medicine medical products.
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