Finally – FDA Offers Guidance on 3-D Printed Products

The agency is the first in the world to provide a comprehensive technical framework to advise manufacturers creating medical products on 3-D printers.

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Not so long ago, the concept of 3-D printed medical devices seemed like something out of a science fiction movie. But the technology is very much a reality, and FDA Commissioner Scott Gottlieb, MD, said the agency is preparing for a significant wave of new technologies that are "nearly certain to transform medical practice."

As part of that preparation, the agency released a comprehensive technical framework this week to advise manufacturers creating medical products on 3-D printers. FDA is the first regulatory agency in the world to do so.

The agency said it reviewed more than 100 3-D printed devices currently on the market, including devices tailored to fit a patient’s anatomy. "Examples include knee replacements and implants designed to fit like a missing puzzle piece into a patient’s skull for facial reconstruction," Gottlieb said.

Even medicine can be manufactured on a 3-D printer, and FDA has already approved a 3-D printed drug that is used to treat seizures and has a more porous matrix than the drug manufactured in the traditional way, enabling the drug to dissolve more quickly in the mouth to work faster, Gottlieb said.

"This is likely just the tip of the iceberg given the exponential growth of innovative research in this field," he said. "We envision that burn patients in the near future will be treated with their own new skin cells that are 3-D printed directly onto their burn wounds. Further down the road, there is the potential for this same technology to eventually be used to develop replacement organs."

3-D printing is even advancing the field of regulatory science, and Gottlieb said FDA has 3-D printing facilities on its campus for agency scientists and engineers to use. The Center for Drug Evaluation and Research's facility, for example, helps FDA scientists to determine how the 3-D printing of drugs impacts inactive ingredients and other drug components as well as the quality control process of manufacturing. FDA engineers in the Center for Devices and Radiological Health have their own 3-D 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 us as regulators to help us understand the policy framework needed to ensure the quality and safety of 3D printed products."

The newly issued guidance was created to help advise device manufacturers on technical aspects of 3-D printing, also known as additive manufacturing, and clarifies what the agency wants manufacturers to include on submissions for 3-D printed devices.

"It includes our thinking on various approaches to 3-D printing, including device design, testing of products for function and durability, and quality system requirements," Gottlieb said. "Overall, it will help manufacturers bring their innovations to market more efficiently 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."

The technical guidance is only intended to provide FDA’s initial thoughts on the emerging technology, and Gottlieb said the agency's recommendations are likely to evolve as the technology does.

"We are already seeing the beginning of this evolution as hospitals and academic centers use their own 3-D printers to create innovative dental implants, replacement knee joints, and experimental heart valves and bone implants for use in clinical studies," he said. "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."

FDA plans to explore the role of nontraditional manufacturing facilities like a hospital operating room or university laboratory, Gottlieb said. The agency also plans to review the regulatory issues related to the bioprinting of biological, cellular, and tissue-based products to determine if additional guidance is needed beyond the recently released regulatory framework on regenerative medicine medical products.

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