3D printing in managing supply disruptions related to COVID-19 pandemic: Food and Drug Administration's current thinking on regulation

摘要

Recent developments and collaborations of pharmaceutical manufacturers, hospitals, and government funded research bodies using 3D printing technology have been highlighted for the management of the healthcare crisis. 3D printing is a process of converting virtual 3D models developed by computer aided design into physical forms upon addition of material layer-by-layer (also known as additive manufacturing). This 3D printing is supposed to revolutionize significantly the healthcare system in the coming years. This process involves a tailored deposition of biomaterials layer by layer such as polylactic acid (PLA), polyvinyl alcohol (PVA), or other suitable pharma-grade polymers, copolymers, and their combinations to formulate three-dimensional custom designs with controlled architecture and composition. Food and Drug Administration (FDA) is currently thinking on regulation to ease the import restrictions for products intended for the detection and diagnosis of COVID-19 to ensure the timely availability of test kits.