The FDA issued a ‘final rule’ to establish a system to adequately identify medical devices
through distribution and use. This rule requires the label of medical devices to include a
unique device identifier (UDI), except where the rule provides for an exception or
alternative placement.
Under the UDI system, the health care community and the public will be able to identify
a device through a UDI that will appear on the label and package of a device. The UDI
system will make it possible to rapidly and definitively identify a device and key
attributes that affect its safe and effective use, and will subsequently facilitate a reduction
in medical errors that result from misidentification of a device or confusion concerning
its appropriate use.
Additionally, the UDI system will also facilitate healthcare product data synchronization
and accurate reporting of adverse events by making it easier to identify the device prior to
submitting a report. Synchronizing healthcare product data globally allows the healthcare
industry to know when and where products are produced and to manage recall and
adverse event reporting to a global standard.
