The incredible potential of 3D printing to transform the medical manufacturing space has not escaped FDA's attention. The agency has already begun receiving 510(k) premarket notification and premarket approval (PMA) submissions for devices in which the technology is used, and there have been some famous instances, such as a 3D-printed trachea that saved an infant's life, where the investigational device exemption pathway offered a route to compliance. As 3D-printed organs and orthopedic devices manufactured at the bedside to fit individual anatomies enter the realm of reality, FDA has announced a public workshop in October 2014 to investigate the fundamental regulatory issues that the technology brings to the surface. Before that, Steven K. Pollack, PhD, Director of the Office of Science & Engineering Labs, FDA, will provide attendees of MD&M East and PLASTEC East with an update of the FDA perspective on 3D printing medical devices. His session is scheduled at 11:30 AM on June 11 at the Javits Convention Center in New York, NY. He recently shared some observations in advance of the event with PlasticsToday.
"The safety and effectiveness of any individual product will continue to be determined through the traditional FDA submission and review process," Pollack told PlasticsToday. "The benefit of 3D printing (or additive manufacturing) is that it greatly expands the ability to create devices that are matched to individual patient anatomy. 3D-printing techniques have different technical considerations than standard manufacturing," he adds, and to establish product safety, "devices manufactured using this technology may need additional or different testing than is normally required of products manufactured using traditional (or subtractive) techniques. Furthermore, traditional manufacturing settings have design controls and systems for complaint handling, and so forth.mAs 3-D printing technology develops, manufacturing may shift to the bedside and FDA may need to provide clarity on these requirements as well as other quality control issues such as material qualifications and sterility."