Your Guide to UDI (Unique Device Identification) for Medical Device Manufacturers
Patient safety with regards to the identification of medical devices, protection from counterfeit devices, and the ability to recall devices quickly and accurately has led to the development of the Unique Device Identification (UDI) system.
The Food and Drug Administration (FDA) created the Unique Device Identification (UDI) system to adequately identify devices from production through distribution and throughout the product's lifecycle and is recognized around the world.
Complying with the UDI standard means manufacturers (“Labelers”) must assign a UDI-compliant code using globally accepted standards to their product, label the products with the UDI appropriately, and then publish the data to the UDI database or GUDID (Global Unique Device Identification Database.)
Final Ruling was passed on September 24, 2013. The deadline for device labels and device packages to bear a UDI is set and will be phased in over several years based on the risk factor of the device.
If you do not have a UDI system in place within the timeline specified by the FDA, you will not be able to sell your product.
Learn how to comply with the labeling and marking requirements of the FDA's Unique Device Identification (UDI) ruling in our ebook by clicking on the PDF below.