On December 5, 2017, the FDA issued the final version of its guidance document for 3D printed devices. The document “Technical Considerations for Additive Manufactured Medical Devices – Guidance for Industry and Food and Drug Administration Staff” is meant to outline the agency’s current thinking about devices made via these processes and will be supplemented by a webinar in January. More information on the webinar is available here.
Additive manufacturing processes / 3D printing is a manufacturing technique that is growing rapidly in the industry, and enabling unique material properties and geometries that are extremely difficult to make via conventional manufacturing, but novel manufacturing processes always opens the door to more questions that need to be answered throughout the regulatory process.
iuvo has worked with a number of our customers to support the preclinical testing of 3D printed devices. Feel free to contact us to learn more about our testing services and experience with 3D printed devices.