On May 10, 2016, the FDA published its Technical Considerations for Additive Manufactured Devices Draft Guidance. The public may submit comments on the Draft Guidance until August 8, 2016.
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.
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 medical devices regulated by the FDA’s Center for Devices and Radiological Health (CDRH), biologics regulated by the FDA’s Center for Biologics Evaluation and Research, and drugs regulated by the FDA’s Center for Drug Evaluation and Research.
3D printers are used to manufacture a variety of medical devices. They have the capacity to print medical devices with complex geometry or features that match a patient’s unique anatomy.
Some devices are printed from a standard design to make multiple identical copies of the same device. Other devices are created from a specific patient’s imaging data. Those devices are called patient-matched or patient-specific.
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).
Currently, research is being done to study 3D printing of living organs, such as a heart or liver. However, this research is in early stages of development.
The 3D printing process can be accomplished using any of several different technologies. The choice of technology can depend on many factors including, but not limited to, the final use of the product and the ease of use of the printer. The most common technology used for 3D printing medical devices is called powder bed fusion.
The powder bed fusion process builds a three-dimensional product from very fine metal or plastic powder. The powder is poured onto a platform and leveled carefully. A laser or electron beam then moves across the powder layer and melts the material it touches. Melted material fuses to the layer below it and to the powder around it to create a solid. Once a layer is completed, the platform moves down and one more layer of carefully leveled powder is placed on top.
The FDA has several 3D 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 device. There are still many research questions that must be answered to fully understand the capabilities of 3D printing of medical devices and the public health benefit of these printers.
The FDA's Center for Devices and Radiological Health (CDRH) regulates firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States.
Like devices made using other manufacturing processes, devices made using 3D printing technology are subject to regulatory requirements. Some requirements apply to medical devices before they are marketed (premarket requirements), and others apply to medical devices after they are marketed (postmarket requirements). Medical devices are classified into Class I, II, and III. Regulatory control increases from Class I to Class III. The device classification regulation defines the regulatory requirements for a general device type. Most Class I devices are exempt from Premarket Notification 510(k); most Class II devices require Premarket Notification 510(k); and most Class III devices require Premarket Approval. A description of device classification and a link to the Product Classification Database is available at: Classification of Medical Devices.
The FDA issued the draft guidance on the Technical Considerations for Additive Manufactured Devices to advise manufacturers who are producing devices through 3D printing techniques. This draft guidance has been published to obtain public feedback and is not final or in effect at this time. The FDA is currently evaluating submissions for new 3D printed medical devices to determine safety and effectiveness. The draft guidance provides manufacturers with recommendations for device design, manufacturing, and testing considerations when developing 3D printed devices. The type of premarket submission required for a device is still determined by its regulatory classification.
This draft guidance is broadly organized into two topic areas, (1) design and manufacturing considerations and (2) device testing considerations. The section of the guidance on design and manufacturing considerations provides technical considerations that should be addressed as part of fulfilling Quality System (QS) requirements for a device, as determined by its regulatory classification or regulation to which it is subject, if applicable. While this draft guidance includes manufacturing considerations, it is not intended to comprehensively address all considerations or regulatory requirements to establish a quality system for the manufacturing of a device.
The section of the guidance on device testing considerations describes the type of information that should be provided in premarket notification submissions [510(k)], premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, de novo requests and investigational device exemption (IDE) applications for a 3D printed device.
See the FDA Announcement on 3D Printing of Medical Devices
See the FDA’s Technical Considerations for Additive Manufactured Devices Draft Guidance