When the US Food and Drug Administration (FDA) begins to implement a global unique device identifier (UDI) system, Class III devicemakers will be the guinea pigs as regulators “work out the kinks,” an agency official says. Because Class III contains the least number of devices and implementing UDI for that class would be relatively cheap, the FDA will slowly test the system on these devicemakers, Jay Crowley, FDA’s senior adviser for patient safety, said.
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.