FAQ on 3D Printing of Medical Devices

FDA has posted “Frequently Asked Questions on 3D Printing of Medical Devices, Accessories, Components, and Parts During the Covid-19 Pandemic.” The document provides the agency’s current thinking for those intending to use 3D printing to assist in meeting demand for certain products during the Covid-19 pandemic. FDA says that while it is possible to use 3D printing to make certain personal protective equipment (PPE), “there are technical challenges that have to be overcome to be effective enough.” For example, 3D-printed PPE may provide a physical barrier, but 3D-printed PPE are unlikely to provide the same fluid barrier and air filtration protection as FDA-cleared surgical masks and N95 respirators, it says. The CDC has recommendations for how to optimize the supply of face masks. The agency directs 3D printer users to previously issued guidance on the Technical Considerations for Additive Manufactured Medical Devices.