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The FDA continues to take creative and flexible approaches to address access to critical medical products in response to COVID-19. During the COVID-19 pandemic, the need for certain medical devices, including personal protective equipment (PPE), may outpace the supply available to health care organizations because of the high demand and overall interruptions to the global supply chain. We recognize that the public may seek to use 3D printing to assist in meeting demand for certain products during the COVID-19 pandemic. As part of our effort to protect the public to the extent possible, we are including answers to frequently asked questions for entities who 3D print devices, accessories, components, and/or parts during the COVID-19 emergency.
A. The FDA has previously issued guidance on the Technical Considerations for Additive Manufactured Medical Devices. This guidance outlines the FDA’s recommendations for 3D-printed devices from the device stage to process validation and acceptance activities of finished devices.
A. PPE includes protective clothing, gowns, gloves, face shields, goggles, face masks, and respirators or other equipment designed to protect the wearer from injury or the spread of infection or illness. While it is possible to use 3D printing to make certain 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. The CDC has recommendations for how to optimize the supply of face masks.
A. 3D-printed PPE can be used to provide a physical barrier to the environment. However, 3D-printed PPE are unlikely to provide the same fluid barrier and air filtration protection as FDA-cleared surgical masks and N95 respirators. The CDC has recommendations for how to optimize the supply of face masks.
A. 3D-printed masks may look like conventional PPE. However, they may not provide the same level of barrier protection, fluid resistance, filtration, and infection control. The CDC has recommendations for how to optimize the supply of face masks.
A. Health care providers should:
A. Entities should use original parts or those with the same specifications, dimensions, and performance, if available. While it is possible to use 3D printing to print certain accessories, components, and parts, some complex products (e.g., working pumps, electronics) are not easily 3D printed. It may help to use plans from original parts when available and verify that any 3D-printed products fit and work properly before they are used in a clinical setting. Entities engaged in 3D printing are encouraged to work with relevant medical device manufacturers.
A. While the FDA understands that 3D printing may occur to provide wider availability of devices during the COVID-19 public health emergency, some devices are more amenable to 3D printing than others. The FDA is willing to discuss these and other issues with manufacturers and facilities. Entities should email COVIDManufacturing@fda.hhs.gov for more information.
A. We recognize that when conventional products are unavailable, some entities are considering printing or purchasing 3D-printed devices. The FDA is working closely with government, industry, and health care facility stakeholders on this and on the broader public health emergency. The FDA recently authorized an Emergency Use Authorization (EUA) for ventilators, ventilator tubing connectors, and ventilator accessories, which could include items such as 3D-printed tubing connectors for multiplexing ventilator use. The FDA also is collaborating with the Department of Veterans Affairs (VA) Innovation Ecosystem, America Makes Public-Private Partnership, and the National Institutes of Health (NIH) 3D Print Exchange, a resource from the National Institute of Allergy and Infectious Diseases at the NIH.
The FDA has included external websites from organizations that are being used to facilitate regulatory and basic science innovation with 3D printing technologies to respond to COVID-19:
If you have questions about 3D printing to meet product demand during the COVID-19 emergency, please email COVIDManufacturing@fda.hhs.gov. For general questions, contact the Division of Industry and Consumer Education (DICE) or email DICE@fda.hhs.gov.