FDA Guidance on 3-D Printing Plans for Future Innovations
FDA has issued a new guidance on “Technical Considerations for Additive Manufactured Medical Devices 3D Printing of Medical Devices.” The “leap-frog” guidance is intended to bridge today’s innovations with expected innovations coming down the road.
FDA commissioner Scott Gottlieb says the new guidance helps the agency prepare for a “significant wave of new technologies that are nearly certain to transform medical practice. 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.”
To date, the agency says it has reviewed more than 100 3D-printed products currently on the market, including replacement knees and the first drug for treating seizures that has a more porous matrix than if made under traditional manufacturing. “This is likely just the tip of the iceberg given the exponential growth of innovative research in this field,” Gottlieb says. “We envision that burn patients in the near future will be treated with their own new skin cells that are 3D 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.”
The new guidance is intended to advise device makers on technical matters related to 3D printing, and clarify what should be included in submissions for 3D-printed medical devices. It includes agency input on various approaches to 3D printing, including device design, testing of products for function and durability, and quality system requirements. The caveat with such leap-frog guidances is that the recommendations are based on “initial thoughts on an emerging technology with the understanding that our recommendations are likely to evolve as the technology develops in unexpected ways,” FDA notes. “We are already seeing the beginning of this evolution as hospitals and academic centers use their own 3D printers to create innovative dental implants, replacement knee joints, and 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.”
Additionally, to keep a handle on the evolving 3D printing technology, the agency has built state-of-the-art 3D printing facilities located on its campus in Silver Spring, MD. A CDER-run facility is conducting research to determine how the 3D printing of drugs impacts inactive ingredients and other drug components as well as the quality control process of manufacturing, Gottlieb says. CDRH engineers have been conducting research 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,” he says. “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.”