As 3D printing continues to make inroads as a medical device manufacturing process—see last week's article on the FDA-approved 3D printed facial implant from Oxford Performance Materials—FDA has scheduled a public workshop in October to discuss the technological challenges and regulatory implications of this technology.
Scheduled for October 8 and 9, 2014, Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing will provide a forum for FDA, medical device manufacturers, researchers, and members of academe to explore these issues that will increasingly confront regulatory agencies in the years ahead. In setting up this workshop, FDA's stated goal is to garner "input regarding technical assessments that should be considered for additively manufactured devices to provide a transparent evaluation process for future submissions."
Along with several FDA officials, speakers will include experts from EOS GmbH, Materialise, Steris Corp., Stratasys, 3D Systems, Renovis Surgical, GE Aviation, and Oxford Performance Materials. Among attendees representing the academic and research communities are Dr. James Yoo, Wake Forest University; John Slotwinski, PhD, Johns Hopkins University Applied Physics Laboratory; Axel Krieger, PhD, Children's National Hospital; and Scott J. Hollister, PhD, University of Michigan.