Some devices are printed from a standard design to make multiple identical copies of the same device. Other devices, called patient-matched or patient-specific devices, are created from a specific patient’s imaging data.
Commercially available 3D printed medical devices include:
Instrumentation (e.g., guides to assist with proper surgical placement of a device),
Implants (e.g., cranial plates or hip joints), and
External prostheses (e.g., hands).
The FDA has several 3D printers that help us better understand the capabilities of 3D printing of medical devices and the public health benefit of this technology. For example, the FDA has printers that use different printing technologies, including powder bed fusion, to evaluate what parts of the printing processes and workflows are critical to ensure quality of the finished medical device.
While 3D printers are often used to create identical copies of the same device, they can also be used to create devices unique to a specific patient. Patient-matched (or patient-specific) devices are created specifically for the patient based on individual features, such as anatomy. They can be based on a template model that is matched to a patient using medical imaging. Patient-matching can be accomplished by techniques such as scaling of the device using one or more anatomic features from patient data.
The FDA regulates 3D printed medical devices through the same pathways as traditional medical devices; therefore they are evaluated according to the safety and effectiveness information submitted to us by the manufacturer. While traditionally manufactured medical devices come in discrete sizes, patient-matched devices can be made in a continuous range of shapes with pre-defined minimum and maximum specifications that we can use to review the devices in the same way as standard sized devices. For instance, the specification may define a minimum and maximum wall thickness or how sharp a curve can be to maintain device performance for its intended use.
There is a provision in federal law that exempts “custom” medical devices from FDA review, but patient-matched devices do not automatically meet all the requirements. For further information on custom device exemptions, please refer to the Custom Device Exemptions guidance.
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Other uses of 3D printing
The use of 3D printing is not limited to medical devices. Other industries and government departments are also interested in its use. For instance, the U.S. Department of Energy (DOE) is investing resources to study 3D printing, and how it can be used to reduce waste by using fewer raw materials and require fewer manufacturing steps. DOE has compiled information on how 3D printing works, the different types of printers and for what they are used. For more information on how 3D printers work and the different printing technologies.
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