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FDA Releases Update on Regulations for 3D Printing of Medical Devices

3D printing, also known as additive manufacturing, 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 an MRI image.

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.

Examples of 3D printed devices.
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. As of December 2015, the FDA has cleared more than 85 3D printed medical devices. Due to its versatility, 3D printing has medical applications in:

Process of 3D Printing Medical Devices

The following sequence of steps is one example of the process:

  • Device Design: A design is created and validated using digital models with pre-specified sizes or digital models matched to a patient’s anatomy.
  • Software Workflow: The digital device design is converted to a buildable file that is sent to the printer. This file will often divide the design into layers, include additional support material to aid printing, and tell the printer where to build the device on the printer platform to prepare it for printing. The 3D printer often also requires some preparation to build different designs by changing settings for the material, type of design, and intended use.
  • Material Controls: Like any manufacturing process, 3D printing needs high quality materials that meet consistent specifications to build consistent high quality devices. To ensure this, procedures, requirements, and agreements called material controls are established between the suppliers, purchasers, and end-users of the material.
  • Printing: The object is printed using the design specifications included in the file.
  • Post-Processing: After printing is complete, one or more post-processing steps may be performed on the device or component. These may include cleaning to remove residual debris, controlled cooling (also called annealing), and/or additional steps such as drilling, cutting, polishing, and sterilization.
  • Process Validation and Verification: Some device or component characteristics can be checked individually after they are produced to make sure they will function properly and meet specifications. This is especially true of geometric features which can be checked quickly and nondestructively. Other functional specifications, like mechanical strength, cannot be checked on every individual production unit because the test could destroy the object or is impractical. To ensure devices meet these specifications, validation of processes occurs before production begins. Process validation ensures that a manufacturing process will produce product that is within defined specifications if specified processing parameters are monitored and controlled.
  • Testing: Device testing is submitted to the FDA to show that it meets regulatory requirements and is reasonably safe and effective for its intended use. During production, samples may be tested to ensure that quality is being maintained. Each device or type of device has its own set of tests that may be based on FDA Guidance documents, international standards or internal process controls. Devices manufactured by 3D printing are generally subject to the same regulatory requirements as non-3D printed devices.

3D printing manufacturing process chart, showing Design leading to Software Workflow, leading to Build which also incorporates Material Control. This leads to post processing and then Testing Considerations. This flow-chart is a simple example of one possible 3D printing manufacturing process. Other possible processes may have different steps or additional branches. The Technical Considerations for Additive Manufactured Devices Draft Guidance describes each step in more detail.

Materials used in Devices

FDA does not typically clear or approve materials for general use in manufacture of medical device. For example, the FDA has approved spinal implants made from titanium alloy, but the FDA has not given blanket approval for the medical use of titanium. Materials used in formulating or constructing medical products are evaluated within the context of FDA’s evaluation of the safety and effectiveness of the medical product for its intended use. For additional information about how the FDA regulates medical devices, see Overview of Medical Device Regulation.

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