Recorded on Thursday, July 28, 2016 2:00 pm
On May 10th the FDA released a draft guidance titled “Technical Considerations for Additive Manufactured Devices” which details FDA’s initial thinking on technical considerations specific to devices using additive manufacturing. The two main topic areas of this draft guidance, Design and Manufacturing Considerations and Device Testing Considerations will be summarized followed by an opportunity to discuss the various technical considerations presented in the document with FDA staff.
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Matthew Di Prima, PhD, Materials Scientist, CDRH/OSEL/DAM, Food and Drug Administration
Dr. Matthew Di Prima received his doctorate in Materials Science and Engineering from the Georgia Institute of Technology and is working as regulatory scientist at the Center for Devices and Radiological Health in the Food and Drug Administration. Among his many duties, he is the head of the Additive Manufacturing Working Group which is spearheading efforts across the Agency to address how additive manufacturing technology affects medical devices and other regulate medical products. These efforts include guidance and standards development, device review harmonization, and performing regulatory science with the intent to foster innovative and high quality products while maintaining they have the same safety and effectiveness that Americans have come to expect.
James Coburn, Senior Research Engineer, Food & Drug Administration
He began his career in clinically-based experimental research, earning a Bachelors and Masters of Mechanical Engineering from Brown University. He was then awarded an international research fellowship to develop tissue engineered regenerative medicine constructs at the National University of Ireland. From there, he spent some time in clinical patient-based research before joining the FDA in 2009. LT James Coburn is now a senior researcher in the FDA’s Center for Devices and Radiologic Health (CDRH) and part of a small team spearheading the Agency’s efforts in Additive Manufacturing. He performs research on patient-based design factors for device development, sits on several Standards committees, and has lead interagency outreach efforts related to emerging technologies and the maker movement. He is the Lead Investigator for the Agency’s Additive Manufacturing Core Facility, the FDA Technical representative to America Makes, and he Co-Chairs the FDA Additive Manufacturing Working Group.
- Comment period ends August 8. Please visit this site to comment: https://federalregister.gov/a/2016-10924
- The draft guidance was followed by publication of a paper in the Open Access journal, 3D Printing in Medicine