On September 27, 2007, the Food and Drug Administration Amendments Act of 2007 was signed into law. This act includes language related to the establishment of a UDI System. This system when implemented will require:

The label of a device to bear a unique identifier, unless an alternative location is specified by 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.