3D Printing a Focus in the FDA’s Regulatory Science
(FDA Voice) The US Food and Drug Administration (FDA) is using 3D Printing to expand their research efforts and expand the agency’s capabilities to review innovative medical products. In fact, 3D printing is fast becoming a focus in the FDA’s practice of regulatory science—that is, the science of developing new tools, standards and approaches to assess the safety, effectiveness, quality and performance of FDA-regulated products.
With 3D printing, the conversion from a virtual computer model to a physical object can occur almost in real time. The printer translates virtual models into digital cross-sections for use as a blueprint for printing, laying down successive layers in different shapes.
Two laboratories in the FDA’s Office of Science and Engineering Laboratories (OSEL) are investigating how the technology may affect the manufacturing of medical devices in the future.
At the Functional Performance and Device Use Laboratory, the FDA has developed and adapted computer-modeling methods to help determine the effect of design changes on the safety and performance of devices when used in different patient populations. The 3D technology enables researchers to tweak the design in ways large and small, and to see precisely how those tweaks will change both fit and functionality. In an era of increasingly personalized medicine, which involves the development of treatments that are tailored to an individual patient or a group that shares certain characteristics, including anatomical features, it helps us to fine-tune our evaluation of patient-fitted products.
At the Laboratory for Solid Mechanics, the FDA is investigating how different printing techniques and processes affect the strength and durability of the materials used in medical devices. What they are discovering will be valuable to reviews of devices down the road; it will help the agency to develop standards and set parameters for scale, materials, and other critical aspects that contribute to product safety and innovation.