3-D printing is a fast-growing new manufacturing technique that builds devices from computerized blueprints or models, by laying material only where it is needed. Through 3-D printing, designers can quickly create a medical device that is anatomically modeled to a specific patient. As discussed in a recent MedWarn Alert, 3D-printed medical devices have already been used successfully in patients. As medical applications for 3D printing technology continue to grow, the regulation these devices pose important questions for regulators including: whether each device would be required to be registered with FDA; how to ensure process verification and validation for devices produced in individual or small batches; how small design changes could affect the safety of a device; and whether materials used in the printing process might affect durability and strength of the device.
To begin to address such issues, FDA's proposed list of discussion topics include:
- Preprinting considerations, including but not limited to:
- material chemistry;
- physical properties;
- part reproducibility; and
- process validation.
- Printing considerations, including but not limited to:
- printing process characterization;
- software used in the process;
- post-processing steps (hot isostatic pressing, curing); and
- additional machining.
- Post-printing considerations, including but not limited to:
- cleaning/excess material removal;
- effect of complexity on sterilization and biocompatibility;
- final device mechanics;
- design envelope; and
 "Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3-D Printing; Public Workshop; Request for Comments," Federal Register, May 19, 2014.
 "Growing Trend: 3D-Printing Medical Devices," MedWarn, April 2, 2014.