FDA provides updated information on 3D Printing of Medical Devices.

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). 3D printing is an additive manufacturing process. Additive manufacturing (AM) is a process that builds an object by iteratively building 2-dimensional (2D) layers and joining each to the layer below, allowing device manufacturers to rapidly alter designs without the need for retooling and to create complex devices built as a single piece

3D printers are used to manufacture a variety of medical devices, including those 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, called patient-matched or patient-specific devices, are created from a specific patient’s imaging data. Like devices made using other manufacturing processes, devices made using 3D printing technology are subject to FDA 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).

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.

Please visit the FDA draft guidance “Technical Considerations for Additive Manufactured Devices” for more information on Design & Manufacturing control and Device Testing Considerations”.

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