The Food and Drug Administration (FDA) issued written guidance for industry and agency staff Dec. 5 covering Technical Considerations for Additive Manufactured (AM) Medical Devices, a broad category of emerging manufacturing concepts known as 3D printing.
This “leapfrog” report represents the FDA’s initial thinking on the design, manufacturing processes, and testing of additively manufactured (AM) devices. According to the FDA, AM involves the sequential accumulation of two-dimensional layers that ultimately produce a three-dimensional object. The techniques allow device manufacturers to rapidly produce alternative designs without the need for retooling to produce complex devices as a single piece.
The FDA guidance outlines technical considerations associated with AM and makes recommendations for testing and characterization for devices that include at least one AM component or additively fabricated step. The terms of the guidance were influenced by a 2014 public workshop and public feedback received on a 2016 draft guidance.
Medical imaging data is commonly used to create 3D printed anatomical structures, AM-facilitated, patient-matched devices (PMDs), and related innovations. Special considerations, such as image-processing algorithms, quality and resolution disparities, rigidity of anatomical structures and disease progression, can impact the accuracy and use of AM devices, developed using imaging data. Due to diagnostic radiology’s expertise with medical imaging and human anatomy, some tech experts believe radiologists are well-positioned to provide a suite of services, such as quality and accuracy assessments, to aid 3D printed device development and applications.
In a written statement, FDA Commissioner Scott Gottlieb noted the agency has reviewed more than 100 devices already on the market that were manufactured on 3D printers. They include patient-matched devices, such as custom knee replacements, tailored to fit the patient’s anatomy. The FDA has even approved the first-ever drug produced on a 3D printer.
The agency views the guidance as a step in the modernization of its regulatory framework. “… the FDA is now preparing for a significant wave of new technologies that are nearly certain to transform medical practice,” Gottlieb wrote. “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.”