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出典:『Wikipedia』 (2011/04/20 17:59 UTC 版)

英語による解説

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The Unique Device Identification (UDI) System is intended to assign a unique identifier to medical devices within the United States. It was signed into law on September 27, 2007, as part of the Food and Drug Administration Amendments Act of 2007. This act includes language related to the establishment of a Unique Device Identification System. When implemented, the new system will require:

• The label of a device to bear a unique identifier, unless an alternative location is specified by the U.S. Food and Drug Administration (FDA) or unless an exception is made for a particular device or group of devices.
• The unique identifier to be able to identify the device through distribution and use
• The unique identifier to include the lot or serial number if specified by FDA