3D Printing of Medical Devices

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.