On July 10, 2012, the Food and Drug Administration (FDA or “the Agency”) published a proposed rule entitled Unique Device Identification System. In the Food and Drug Administration Amendments Act of 2007 (FDAAA), Congress directed FDA to issue regulations to implement a unique device identifier (UDI) system. Following four pilot programs and input from industry, healthcare professionals, hospitals, payors, and patients, FDA drafted and promulgated the proposed rule.

In its press release regarding the UDI proposed rule, FDA lists the benefits that the Agency believes will result from implementation of a UDI system. These benefits are: (1) more accurate reporting, reviewing, and analyzing of adverse events, leading to quicker corrective actions; (2) reduced medical errors through more rapid and precise identification of a device and its characteristics; (3) consistency in the way medical devices are referenced in electronic health records and clinical information systems; (4) more effective management of recalls through standardized identifiers; and (5) a foundation for a secure global distribution chain, thereby helping to address counterfeiting, diversion, and emergencies. The preamble to the proposed rule provides further detail on what FDA believes are the benefits of its proposed rule. The Agency recognizes that the full benefits of the proposed UDI system will not be realized until healthcare facilities adopt or modify information technology systems that can store and access UDI information across administrative, clinical (including electronic health records), and payment systems. Under the proposed rule, however, these facilities are not required to modify their existing systems or to adopt new ones.

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