After years of development, an extended comment period by industry and final review by the Office of Management and Budget, the FDA has at last issued the final rule on unique device identification. Mandated by the FDA Amendments Act of 2007, unique device identifier regulation is aimed at reducing medical device-related errors, injuries and deaths.

The UDI rule establishes a system that, once fully implemented, will provide a consistent and automated way to identify and track medical devices distributed within the United States. Specifically, it requires that medical devices be assigned a unique code that is tied to associated device and packaging information housed in a central FDA database. Such a system ensures a substantially higher degree of oversight in the medical devices industry which, ultimately, holds the promise of a significantly higher level of patient safety. And, while UDI regulation also promises numerous business benefits to organizational stakeholders, it also opens the doors to a host of data challenges, particularly for those required to comply. Yet, as this and subsequent articles will point out, enterprise information management, with a focus on data governance, data quality management and product information management, can facilitate compliance efficiently and effectively in a timely manner.

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