FDA Ushering in New Era of 3D Printing of Medical Products
FDA Commissioner Scott Gottlieb, M.D., says the FDA is beginning a new era of 3D printing of medical products in providing a comprehensive regulatory pathway that will keep pace with advances and facilitate greater access to safe and effective innovations taking shape.
Already, the FDA has reviewed more than 100 medical devices on the market that were manufactured on 3D printers. Examples include knee replacements and implants designed specifically for a patient’s anatomy to fit like a missing piece into a patient’s skull. 3D printing is also applicable to drugs, as a 3D printer can create a more porous matrix compared with traditional drug manufacturing, thereby enabling the drug to dissolve more rapidly and work faster.
The FDA has also put state-of-the-art 3D printers in its facilities so that FDA scientists are able to conduct research to determine how the 3D printing impacts the drug’s ingredients. Having direct access to the manufacturing process will allow the FDA to better regulate and asses 3D printed drugs and initiate a quality control process for their manufacturing. FDA engineers are also use these 3D facilitates 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.
To read the FDA’s new guidance on the technical aspects of 3D printing, please visit: https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM499809.pdf