FDA is monitoring the emerging field of 3D printing and additive manufacturing, an area FDA once considered a “futuristic technology on the distant horizon.”
As the agency prepares for its first big wave of 3D printed products, it has put in place a technical framework and released its new guidance document, “Technical Considerations for Additive Manufactured Devices,” in December 2017.
In a statement released with the guidance, FDA Commissioner Scott Gottlieb, MD, notes, “Patients have already benefitted from 3D printed medical products through access to personalized devices and innovative drugs that have led to significant health improvements. But the FDA is now preparing for a significant wave of new technologies that are nearly certain to transform medical practice,” he says. “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 new guidance was issued to help advise device manufacturers on technical aspects of 3D printing, which FDA refers to as additive manufacturing. It is intended to clarify what FDA recommends that manufacturers include in their submissions for 3D printed medical devices.
“It includes our thinking on various approaches to 3D printing, including device design, testing of products for function and durability, and quality system requirements,” says Gottlieb. “Overall, it will help manufacturers bring their innovations to market more efficiently by providing a transparent process for future submissions and making sure our regulatory approach is properly tailored to the unique opportunities and challenges posed by this promising new technology.”
Gottlieb points out that this guidance is what FDA calls a “leap-frog” guidance because it is designed to provide FDA’s initial thoughts on an emerging technology, he says, “with the understanding that our recommendations are likely to evolve as the technology develops in unexpected ways.”
He notes that the agency is already seeing the beginning of this evolution as hospitals and academic centers use their own 3D printers to create innovative dental implants, replacement knee joints, and experimental heart valves and bone implants for use in clinical studies. FDA has reviewed more than 100 devices currently on the market that were manufactured on 3D printers.
As innovations in 3D printing impact healthcare by lowering costs and personalizing treatments, it is great to see FDA create this pathway that can respond appropriately to the “unique attributes” created through 3D printing and additive manufacturing.
Editor and Director of Medical Content