On September 27, 2007, the Food and Drug Administration Amendments (FDA) Act of 2007 was signed into law. This act includes language related to the establishment of a Unique Device Identification System. This new 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


FDA website

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