FDA seeks to pave regulatory pathway that keeps pace with advances in 3D-printed medical devices

FDA logo3D printing has taken manufacturing by storm, and that also includes the fabrication of medical devices, medications and human body parts. FDA Commissioner Scott Gottlieb, MD, noted in a statement that many patients have already benefitted from 3D-printed medical products leading to improvements in health.

In preparation for a “wave of new technologies,” FDA is 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,” wrote Gottlieb.

To date, FDA has reviewed more than 100 devices currently on the market that were manufactured on 3D printers, including patient-matched devices tailored to fit a patient’s anatomy. For example, there are knee replacements and implants designed to fit like a missing puzzle piece into a patient’s skull for facial reconstruction. FDA also approved the first drug produced on a 3D printer, which is used to treat seizures, that is more porous and dissolves faster in the mouth than legacy products.

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“We’re also helping to advance the field of regulatory science with state-of-the-art 3D-printing facilities located on the FDA’s campus,” said Gottlieb in his statement. “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. This research also helps inform us, as regulators, to help us understand the policy framework needed to ensure the quality and safety of 3D printed products.”

On Dec. 4, FDA announced the issuance of new guidance to help advise device manufacturers on technical aspects of 3D printing, referred to as additive manufacturing, that clarifies what FDA recommends manufacturers include on submissions for 3D-printed medical devices. It includes FDA’s thinking on various approaches to 3D printing, including device design, testing of products for function and durability, and quality system requirements. Overall, it will help manufacturers bring their innovations to market more efficiently by providing a transparent process for future submissions and making sure FDA’s regulatory approach is properly tailored to the unique opportunities and challenges posed by this promising new technology, said Gottlieb’s statement.

“But this technical guidance—categorized as ‘leap-frog’ guidance because it helps bridge where we are today with innovations of tomorrow—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,” Gottlieb stated. “We are already seeing the beginning of this evolution as hospitals and academic centers use their own 3D printers to create innovative dental implants, replace knee joints, and [produce] experimental heart valves and bone implants for use in clinical studies. An increasing number of surgeons across the country have been saving infants born with a life-threatening breathing condition by creating patient-matched 3D-printed splints to install in their patients’ tiny airways, which expand and degrade as the babies grow.”

Gottlieb added that FDA is working to establish a regulatory framework for how it plans to apply existing laws and regulations that govern device manufacturing to non-traditional manufacturers like medical facilities and academic institutions that create 3D-printed personalized devices for specific patients they are treating.

FDA also plans to review the regulatory issues related to bioprinting in the recently released regulatory framework on regenerative medicine. The Center for Biologics Evaluation and Research has recently interacted with more than a half-dozen manufacturers who have expressed interest in using 3D printing in some capacity to produce their medical products.

“These steps are part of our broader effort to help ensure our regulatory framework is properly matched to the unique attributes of the new technologies we’re being asked to review,” said Gottlieb. “3D printing is certain to alter the daily practice of medicine where patients will be treated with medical products manufactured specifically for them. The FDA has an important mission to help advance these efforts while also protecting patients who depend on medical products to be safe and effective.”

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