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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