Articles
Analytics & Research, Cost Management, Data Standards, Financial Management, Unique Device Identifier (UDI), Medical Device Technology
How the FDA's UDI Regulation Benefits the Healthcare Supply Chain, Patient Care and the Bottom Line
Medical device manufacturers have been working hard to comply with the new Unique Device Identification (UDI) regulations from the FDA that are aimed at bolstering the safety of medical devices. The UDI system, which the agency says will be phased in over several years, is intended to improve patient safety, modernize device post-market surveillance, and facilitate medical device innovation. The FDA program leverages human and machine-readable UDI labeling for identifying medical devices, and device labelers must submit information about each device to the FDA’s Global UDI Database.