Leslie Kux, Assistant Commissioner for Policy at the Federal Register, posted an event notice regarding a public workshop on “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3-D Printing,” hosted by FDA. The intention of the workshop is to provide a forum for discussion on technical challenges and solutions of 3-D printing.
3-D printing, or additive manufacturing, is a technique used to create devices by layering necessary material based on a computerized model or blueprint. This technique allows designers to make quick alterations for prototype iteration or production of multiple product designs. Combining this technology with a patient’s own medical imaging, anatomically matched devices or surgical guides can be created.
FDA has already received submissions for additively manufactured medical devices and is forecasting substantial growth in the industry over the next ten years, which is motivation for hosting this workshop. FDA is seeking the perspective of stakeholders by discussing scientific and technical challenges associated with additive manufacturing. The information gathered at the workshop may aid to the development of new draft guidance and standards to ensure patient safety and support innovation.
To read the full event notice, click here.