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● Industry Watch UDI

FDA fi nalizes UDI system to identify medical devices T e U.S. Food and Drug Administration announced a

fi nal rule for the unique device identifi cation system (UDI) that, once implemented, will provide a consistent way to identify medical devices. T e UDI system has the potential to improve the qual- ity of information in medical device adverse events reports, which will help the FDA identify product problems more quickly, better target recalls, and improve patient safety. T e FDA has worked closely with industry, the clinical com- munity and patient and consumer groups in the develop- ment of this rule. T e UDI system consists of two core items. T e fi rst is a unique number assigned by the device manufacturer to the version or model of a device, called a unique device identifi er. T is identifi er will also include production-specifi c informa- tion such as the product’s lot or batch number, expiration


Why healthcare needs the cloud

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date, and manufacturing date when that information ap- pears on the label. T e second component is a publicly searchable data- base administered by the FDA, called the Global Unique Device Identifi cation Database (GUDID) that will serve as a reference catalogue for every device with an identifi er. No identifying patient information will be stored in this device information center. T e FDA plans to phase in the UDI system, focusing

fi rst on high-risk medical devices. Many low-risk devices will be exempt from some or all of the requirements. Once fully implemented, the UDI system rule is expected to have many benefi ts for patients, the healthcare system and the device industry. It will enhance the ability to quickly and effi ciently identify marketed devices when recalled, improve the accuracy and specifi city of adverse event reports and provide a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion. It will also off er a clear way of documenting device use in electronic health records and clinical information systems. T e FDA issued the proposed rule requesting input

from industry, the clinical community and patient and consumer groups on July 10, 2012. T e UDI system builds on current device industry standards and processes, and refl ects substantial input from the clinical community and the device industry during all phases of its development. In addition, the FDA worked to reduce the burden on industry by building upon systems already in place. T e UDI system is a key component of the National Medi- cal Device PostMarket Surveillance System proposed in eptember 2012. In general, high-risk medical devices (Class III) will be

required to carry unique device identifi ers on their label and packaging within one year and this number and cor- responding device information must be submitted to the new database. Manufacturers will have three years to act for most Class II (moderate risk) devices. Manufacturers of Class I devices not exempt from UDI requirements will have fi ve years to act. T e rule may be accessed at www. Reports/EconomicAnalyses/UCM368961.pdf


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