The UDI system established by this rule builds on international regulatory cooperation activities and makes use of internationally recognized standards relating to unique identification and data exchange. The rule specifies the technical requirements of a UDI. Each UDI will consist of two portions:
* A device identifier that corresponds to the specific version or model of the device and the labeler of the device (the labeler is the person who causes a label to be applied to a device, or who causes the label to be modified, with the intent that the device will be introduced into interstate commerce without any subsequent replacement or modification of the label; in most instances, the labeler would be the device manufacturer, but the labeler may be a specification developer, a single-use device reprocessor, a convenience kit assembler, a repackager, or a relabeler), and
* A production identifier that more precisely identifies the specific device by providing variable information, such as the lot or batch, the serial number, expiration date, the date of manufacture, and, for human cells, tissues, or cellular and tissue-based products (HCT/Ps) regulated as devices, the distinct identification code required in
The rule explains when a UDI is required and when its use must be discontinued. The rule requires all UDIs to be issued under a system operated by an
Whenever a device must bear a UDI, the labeler of that device is required to submit information concerning the device to the GUDID, which will facilitate the rapid identification of the device and the labeler and provide links to other
The rule provides for certain exceptions and alternatives, ensuring that the costs and burdens are kept to a minimum.
As discussed in Section VII.B, "Compliance Dates,"
Costs and Benefits
Economic Data: Costs and Benefits Accounting Statement [2012 dollars] Category Primary Low High Units estimate estimate estimate Year Discount Period Notes dollars rate covered (percent) Benefits: Annualized 7 Monetized $ 3 millions/ year Annualized 7 Quantified 3 Qualitative More accurate and prompt identification of device related adverse events should lead to more rapid action to reduce the inci- dence of the adverse events and to more effectively target and manage medical device recalls. Costs: Annualized
$85.7 $48.8 $122.52012 7 10 years Costs to foreign labelers are not included. Monetized $84.147.9 120.2 2012 3 10 years millions/ year Annualized 7 Quantified 3 Qualitative Transfers: Federal 7 3 Annualized 3 Monetized