Now that 3D printing of medical devices, medications, and human tissue has become a promising reality, the U. S. Food and Drug Administration (FDA) is preparing for a wave of new technologies that are nearly certain to transform medical practice, said FDA Commissioner Scott Gottlieb, MD. As a result, the agency is taking steps to provide a more comprehensive regulatory pathway to keep pace with those advances, as well as to help facilitate efficient access to safe and effective innovations that are based on these technologies, Gottlieb said.
The FDA has reviewed more than 100 devices currently on the market that were manufactured on 3D printers, including patient-matched devices tailored to fit their anatomy. The agency is also helping to advance the field of regulatory science with state-of-the-art 3D-printing facilities located on its campus. For example, FDA engineers in the Center for Devices and Radiological Health have been conducting research using their own 3D-printing facility to investigate the effect of design changes on the safety and performance of devices, and to determine how iterative changes alter the device’s fit and functionality. Such answers could, for example, help improve the effectiveness and comfort of prosthetic devices, Gottlieb said. “This research also helps inform the FDA as regulators to help us understand the policy framework needed to ensure the quality and safety of 3D printed products,” he said.
The FDA recently issued new guidance to help advise device manufacturers on technical aspects of 3D printing, referred to as additive manufacturing, that clarifies what the FDA recommends manufacturers include on submissions for 3D-printed medical devices. It includes the agency’s rationale on various approaches to 3D printing, including device design, testing of products for function and durability, and quality system requirements. In addition, to help ensure the safety and effectiveness of these products, the FDA is working to establish a regulatory framework for how it plans to apply existing laws and regulations that govern device manufacturing to nontraditional manufacturers, such as medical facilities and academic institutions, that create 3D-printed personalized devices for specific patients they are treating. Developing a transparent policy on 3D printing remains an important next step for the FDA, Gottlieb said.