FDA Takes on 3-D Printing in Healthcare With Initial Guidance Document

The US Food and Drug Administration (FDA) released new guidance this week addressing regulatory requirements related to 3-D printing in medicine. Along with a statement from FDA Commissioner Scott Gottlieb, MD, the move reflects the agency’s efforts to finalize their initial recommendations regarding the emerging field of technology and its use in the healthcare space.

Within the past year especially, interest around 3-D printing and its applications in the field of structural heart interventions has grown. Several institutions have built in-house 3-D printing laboratories, mostly to provide handheld models that can be used for procedure planning and training, and skeptics who once thought of the technology as a novelty are now convinced that it has clinical utility. However, no guidelines exist regarding the proper usage of 3-D printers and their products.

“Patients have already benefitted from 3-D 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,” Gottlieb writes. “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 guidance document released yesterday was drafted in an effort to clarify “what the FDA recommends manufacturers include on submissions for 3-D-printed medical devices,” he adds. It includes suggestions on device design, product testing, and quality-system requirements. “Overall, it will help manufacturers bring their innovations to market more efficiently,” Gottlieb explains, “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 says the document provides “‘leap-frog’ guidance” given that it provides a link between today’s technologies and tomorrow’s innovations, stressing it “is only intended to provide the FDA’s initial thoughts on an emerging technology with the understanding that our recommendations are likely to evolve as the technology develops in unexpected ways.”

The FDA plans to create a greater regulatory framework to govern the safety and efficacy of 3-D printing in medicine, keeping in mind that this technology is being used in “nontraditional manufacturing facilities like a hospital operating room or university laboratory,” according to Gottlieb.

“3-D printing is certain to alter the daily practice of medicine where patients will be treated with medical products manufactured specifically for them,” he concludes.

‘A Good First Step’

Commenting to TCTMD in an email, Dee Dee Wang, MD (Henry Ford Hospital, Detroit, MI), who runs both the structural heart imaging department for her hospital as well as the 3-D printing program at the Henry Ford Innovation Institute, said that while the FDA document is more of a “general blanket statement” on the topic, “it is a good first step to recognizing that there is a role for this technology in medicine.”

Additionally, she said the document is primarily “aimed at industry,” so it wouldn’t be surprising if the FDA released regulations “prior to everyone trying to market themselves as a 3-D printing medical company.”

Within cardiology specifically, Wang said she hopes the FDA reaches out to experts in the field “so we can help formulate the future 3-D printing and modeling recommendations, as it is very important to have physicians involved in the process to ensure that the patients’ best interests are kept in mind.”

For the time being, this statement will not affect those working with 3-D modeling in the cardiovascular space directly, she said. “It is [recognized] that 3-D printing has arrived, and more work needs to be performed to bring industry and clinical experts together to help pave the next steps.”

To help make this process smoother, Wang said a “call to action” is needed for the creation of a cardiology 3-D printing and imaging society, one “with our own appropriateness criteria and guidelines to help the FDA. The time is now.”

Photo Credit: Dee Dee Wang, MD (Henry Ford Hospital, Detroit, MI)