US FDA provides guidance on 3D printing of medical devices
The US Food and Drug Administration (FDA) has announced guidance on additive manufacturing or three-dimensional (3D) printing of medical devices, medications and human tissue.
The agency advises manufacturers on different approaches to printing, design and testing the printed products for function, durability and quality system requirements.
FDA Commissioner Scott 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.”
To date, the agency has reviewed more than 100 devices manufactured on 3D printers, including patient-matched devices such as knee replacements and implants designed to fit the anatomy of a patient.
The FDA also approved a drug formulated for the treatment of seizures with a more porous matrix to allow quick dissolution and rapid action.
It is expected that the technology can aid in treating burn patients by directly 3D printing their own new skin cells onto burn wounds, as well as to develop replacement organs.
The FDA is working on a transparent regulatory framework for governing 3D device manufacturing to ensure the safety and effectiveness of such products.
Gottlieb added: “Developing a transparent policy on 3D printing remains an important next step for us, and we plan to explore the role of non-traditional manufacturing facilities like a hospital operating room or university laboratory.
“The FDA also plans to review the regulatory issues related to the bioprinting of biological, cellular and tissue-based products in order to determine whether additional guidance is needed beyond the recently released regulatory framework on regenerative medicine medical products.”
To accelerate research and regulatory science, the agency is offering its 3D printing facilities, Centre for Drug Evaluation and Research (CDER) and the Centre for Devices and Radiological Health (CDRH).