FDA to Hold 3-D Printing Public Workshop

The U.S. Food and Drug Administration (FDA) has announced an upcoming public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3-D Printing.” According to the agency, the purpose of this workshop is to provide a forum for the FDA, medical device manufactures, additive manufacturing companies, and academia to discuss technical challenges and solutions of 3-D printing. The agency is calling for input regarding technical assessments that should be considered for additively manufactured devices to provide a transparent evaluation process for future submissions.

The FDA notes that 3-D printing, traditionally known as additive manufacturing, has been rapidly growing, and is just recently beginning to enter mainstream use for medical device manufacturing.

“This technology unlocks new avenues for creativity and innovation for medical device designers,” The agency statement reads. “For example, it can facilitate the production of devices with intricate structures that were previously impractical or impossible. Current industry applications include using it as an alternative device production method for traditional components or as a primary method to create patient-matched devices. As the technology matures, additional capabilities may be incorporated into medical devices. FDA has begun to receive submissions using additive manufacturing for both traditional and patient-matched devices, and we see many more on the horizon. Industry forecasts project significant growth of additive manufacturing in both traditional and innovative environments by 2025.”

Because of its rapid growth, the FDA is holding a forum in which manufacturers and other stakeholders in the medical device space can convene to discuss technical challenges, process verification and validation, and other pertinent issues.

The stated goals of the public workshop are to develop a more complete understanding of the technical challenges and solutions in additive manufacturing across a variety of materials and printing technologies that will affect safety and effectiveness of medical devices; create awareness of these technical challenges and collaboratively develop solutions and best practices to ensure the performance and reliability of these devices; create a forum for open dialogue among stakeholders to share lessons learned and best practices for overcoming the technical challenges presented by additive manufacturing; promote innovation in technology and processes to ensure and improve device performance and reliability; and coordinate future collaborations in the development of educational materials, standards, and guidance.

The workshop will be held October 8-9 at the FDA’s White Oak campus.