The U.S. Food and Drug Administration has finalized its guidance on 3D-printed medical devices.
The FDA is now preparing for a significant wave of new additive manufacturing technologies that are already transforming medical practice. The agency is working to provide a more comprehensive regulatory pathway that keeps pace with advances in the field 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. The FDA 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.
The organization is looking to advance the field of regulatory science with state-of-the-art 3D printing facilities located on the FDA’s campus. The Center for Drug Evaluation and Research’s (CDER) facility hopes to enable FDA scientists to conduct 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. 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.
The new guidance the FDA is issuing today is meant to help advise device manufacturers on technical aspects of 3D printing that clarifies what the FDA recommends manufacturers include on submissions for 3D-printed medical devices. It includes the organization's stance on various approaches to 3D printing, including device design, testing of products for function and durability, and quality system requirements.
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