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3D Printing of Medical Devices

Coronavirus COVID-19 Information Related to 3D Printing of Medical Devices

  • FAQs on 3D Printing of Medical Devices, Accessories, Components, and Parts during the COVID-19 Pandemic

Overview

3D printing is a type of additive manufacturing. There are several types of additive manufacturing, but the terms 3D printing and additive manufacturing are often used interchangeably. Here we will refer to both as 3D printing for simplicity.

3D printing is a process that creates a three-dimensional object by building successive layers of raw material. Each new layer is attached to the previous one until the object is complete. Objects are produced from a digital 3D file, such as a computer-aided design (CAD) drawing or a Magnetic Resonance Image (MRI).

The flexibility of 3D printing allows designers to make changes easily without the need to set up additional equipment or tools. It also enables manufacturers to create devices matched to a patient’s anatomy (patient-specific devices) or devices with very complex internal structures. These capabilities have sparked huge interest in 3D printing of medical devices and other products, including food, household items, and automotive parts.
 

3D printed (left to right, top) models of a brain, blood vessel, surgical guide, and (bottom) medallion printed on FDA 3D printers.

Medical devices produced by 3D printing include orthopedic and cranial implants, surgical instruments, dental restorations such as crowns, and external prosthetics.

Due to its versatility, 3D printing has medical applications in:

  • Medical devices regulated by FDA’s Center for Devices and Radiological Health (CDRH),
  • Biologics regulated by FDA’s Center for Biologics Evaluation and Research, and
  • Drugs regulated by FDA’s Center for Drug Evaluation and Research
     

 Medical device manufacturers should refer to FDA guidance documents and Quality Systems regulations for more information on specific applications.

Additional Resources

  • The 3Rs of 3D Printing: FDA's Role Learn how the FDA reviews and researches 3D printed medical products to protect the public health.
  • Technical Considerations for Additive Manufactured Medical Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 803KB) FDA’s thinking on technical considerations specific to devices using additive manufacturing, the broad category of manufacturing encompassing 3D printing.
  • How 3D Printers Work
    A resource from the Department of Energy and includes descriptions of different types of printing processes
  • NIH 3D Print Exchange
    Offers a unique set of models, learning resources and tutorials to create and share 3D-printable models related to biomedical science. The goal of the project is to facilitate the application of 3D printing in the biosciences.
  • American Society of the International Association for Testing and Materials (ASTM) International Committee F42 on Additive Manufacturing Technologies
    This is a collaborative, consensus organization that has published standards and test methods for additive manufacturing and 3D printing.
  • America Make
    A public private partnership whose members, including the FDA, are working together to innovate and accelerate 3D printing to increase our nation’s global manufacturing competitiveness.

 

3D Printing of Medical Devices, Accessories, Components, and Parts During the COVID-19 Pandemic

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.

Q. What are the FDA's general recommendations for 3D printing medical devices?

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.

Q. Can 3D printing be used to make gowns, masks, respirators, and other types of personal protective equipment (PPE)?

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.  

Q. Can I use PPE made by 3D printing?

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. 

Q. Will 3D-printed masks provide the same fluid barrier protection and air filtration as FDA-cleared surgical masks and N95 respirators?

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. 

Q. What should health care providers do if using a 3D-printed mask?

A. Health care providers should:

  • Check the 3D-printed mask's seal for leaks.
  • Confirm that they can breathe through any makeshift filter materials.
  • Exercise caution in surgical environments where the need for liquid barrier protection and flammability is a concern.
  • Recognize that the mask may not provide air filtration enough to prevent transmission of infectious agents.
  • Safely dispose of infectious materials and disinfect any part they intend to reuse.

Q. Can accessories, components, or parts for medical devices be 3D printed?

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.

Q. Can entire medical devices be 3D printed?

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 [email protected] for more information.

Additional Resources

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:

  • Coronavirus Disease (COVID-19)
  • America Makes (the National Additive Manufacturing Innovation Institute)
  • Department of Veterans Affairs Innovation Ecosystem
  • National Institutes of Health 3D Print Exchange
  • Medical Glove Conservation Strategies - Letter to Health Care Providers

Contact Information

If you have questions about 3D printing to meet product demand during the COVID-19 emergency, please email [email protected]. For general questions, contact the Division of Industry and Consumer Education (DICE) or email [email protected].

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PUMPKIN WITH SKELETON

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Shuma - Gorath Miniature Free 3D Printable Model

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Christmas pixie door

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flower Chinese bottle

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Art category bestsellers nine0037

Archaeopteryx nibbler

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FLEXIBLE STANDING STANDING YETI

2,80 €

CHRISTMAS TREE WITH LEGS

2. 82 €

☃️ Monster Snowman - XMAS TREE ORNAMENT☃️

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Adorable articulated axolotl, imprinted body, snap head, cute flexi

€3.30

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