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FDA finalizes new rule for unique device identification system

The US Food and Drug Administration (FDA) has finalized a new rule for the unique device identification (UDI) system, designed to provide a consistent and clear way to identify medical devices.

The FDA worked jointly with industry, clinical community and patient and consumer groups since July 2012 to develop the UDI system that has two core items.

First core item, called a unique device identifier, is a unique number given by the product manufacturer to the version or model of a device and the second core item is the global unique device identification database (GUDID), a publicly searchable database administered by the FDA.

The manufacturer will also include product’s lot or batch number, expiration date, and manufacturing date when that information appears on the label and GUDID will serve as a reference catalogue for every device with an identifier.

UDI system will enhance the ability to quickly and efficiently identify marketed devices when recalled, improve the accuracy and specificity of adverse event reports and provide a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion, and also offers a clear way of documenting device use in electronic health records and clinical information systems.

The FDA plans to introduce the UDI system, a key component of the National Medical Device PostMarket Surveillance System proposed in September 2012, first for high-risk medical devices, while exempting many low-risk devices from some or all of the requirements in the final rule.