Innovation in Medical Device - Are You ready for UDI?

In 2007, the US Congress passed legislation directing the Food and Drug Administration (FDA) to develop regulations establishing a unique device identification (UDI) system for medical devices. On September 24, 2013 the final FDA rule took effect in the US. Comparable legislation that is expected from other areas of the world will set up the potential for a global system for UDI. FDA Unique Device Identification (UDI) System UDI: Global Scope A globally consistent system to track medical devices will benefit public safety by reducing medical errors and improving post?market surveillance of devices, enabling manufacturers and regulators to identify product and safety issues more quickly and precisely. The system should also ease the complexity of international product registrations and eventually provide a foundation for a global, secure distribution chain, helping to reduce counterfeiting and creating supply chain efficiencies for manufacturers, distributors and end users. 2

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