FDA to Hold Public Workshop on 3D Printing Medical Devices

In a May 19, 2014 Federal Register notice, FDA announces that it will hold a public workshop October 8-9, 2014, on the technical considerations of additive manufacturing, also known as 3-D printing.  "The purpose of this workshop is to provide a forum for FDA, medical device manufacturers, additive manufacturing companies, and academia to discuss technical challenges and solutions of 3-D printing. "  To permit the widest possible opportunities for public input, the agency is also soliciting electronic or written comments on all workshop topics.

 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;
  • recyclability;
  • 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
  • verification.

As the FDA receives an increasing number of submissions using 3D-printing for both traditional and patient-matched devices, how 3-D printed medical devices will be overseen by the FDA has become a pressing issue.  FDA hopes that ideas generated from the workshop will facilitate development of new draft guidances and/or standards.

[1] "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.
[2] "Growing Trend: 3D-Printing Medical Devices," MedWarn, April 2, 2014.