Once considered a futuristic technology on the distant horizon, 3D printing of medical devices, medications and human tissue is quickly becoming a promising reality. Patients have already benefitted from 3D 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. 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 FDA has reviewed more than 100 devices currently on the market that were manufactured on 3D printers. These include patient-matched 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.
FDA is also approved the first drug produced on a 3D printer, which 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 rapidly in the mouth to work faster.
FDA engineers in the Center for Devices and Radiological Health (CDRH) 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.
To keep pace with evolving 3D printing technology and to encourage and support innovation in this field, the FDA has led the world in advancing efforts to provide a comprehensive policy framework to manufacturers and a more efficacious pathway to getting state-of-the-art medical products into the hands of patients and healthcare providers.
One example has been CDER’s Emerging Technology Program, which provides opportunities for early engagement regarding innovative approaches to pharmaceutical product design or manufacturing, including additive manufacturing of pharmaceuticals. More than a dozen pharmaceutical manufacturers have formally or informally been in contact with CDER regarding the use of 3D printing to manufacture drugs.
FDA is issuing new guidance to help advise device manufacturers on technical aspects of 3D printing, referred to as additive manufacturing, that clarifies what the FDA recommends manufacturers include on submissions for 3D-printed medical devices. It includes 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 our regulatory approach is properly tailored to the unique opportunities and challenges posed by this promising new technology.
