US legislation Food and Drug Administration (FDA)

On 17 December 2013, the US Food and Drug Administration (FDA) accredited GS1 as a UDI Approved Agency. 

The US FDA introduced this regulation in September 2013 to create a global, unique system for the identification of all medical devices sold in the United States. The US FDA wants to ensure patient safety and better protect the supply chain in the healthcare sector with this regulation. These regulations stipulate that: 

  • Manufacturers must affix a unique UDI number to each medical device; 
  • A UDI must be applied in human-readable form and in the form of a barcode. This information must be applied to all labels as standard; 
  • The master data of the medical device must be transmitted to the Global Unique Device Identification Database (GUDID). 

Within the framework of the UDI system, the US FDA has developed the GS1 Global Unique Device Identification Database (GUDID). This database contains some basic elements of each medical device for which a UDI exists. Manufacturers are responsible for publishing and updating the data in the database. 

Manufacturers can now use My Product Manager to publish their master data in GUDID.  

Download the brochure here: GS1 GDSN for UDI