If you are involved in your organization’s compliance program for Unique Device Identification (UDI), you have probably heard a lot of “G terms” being thrown around, such as “GS1,” “GTIN” and “GDSN.”
But what do these terms mean and where do they fit in with FDA’s UDI requirements?
Once a product is defined as a medical device by it’s intended use and indications for use, The United States Food and Drug Administration (FDA) requires that each medical device that is placed on the US market must be labeled with a UDI number. Device manufacturers must assign a UDI number to each version or model of a device, and the UDI number must be readable in both human format and in AutoID format. This regulation allows medical devices to be easily identifiable, helping to increase patient safety and enhance the care they receive.
UDI regulations have also spread to the EU and are continuing to spread through the world as they benefit the medical industry everywhere.
GS1, also known as Global Standards One is a non-profit organization that develops and sets international standards for supply chain data across many different industries. When you see a barcode, whether on a box of cereal at a grocery store or on an ultrasound machine in a hospital, there is a very good chance it is formatted according to GS1 standards.
GTIN, or Global Trade Item Number, is a globally unique identification key maintained by the GS1 organization and has applications in various industries. Because it is already widely in use across the healthcare industry, the GTIN is one of three standards allowed by FDA to be used as the Device Identifier (DI) portion of a UDI.
Using GTINs as DIs allows device labelers to connect their UDI data records to a global network of product information. The GDSN (Global Data Synchronization Network) is used by trading partners throughout the healthcare industry (including manufacturers, distributors and hospital networks) to exchange product data in a standard format. By sharing UDI data with a GDSN-certified data pool, medical device labelers can ensure that the data submitted to FDA is made available at the same time to their trading partners.
Please note: Althugh using GTIN as your primary DI is the first step toward the exchange of product data through the GDSN, merely using GTIN does not mean your data is in the GDSN. Product data must be placed into a GDSN-certified data pool.
In addition to simplifying the exchange of device product data for the U.S. market, an investment in the GDSN standard will allow device labelers to leverage their previous UDI compliance efforts to meet upcoming initiatives. These mandates of regulatory authorities outside of the U.S. will likely include UDI in the EU and UK eProcurement.
While the UDI requirements of the IMDRF, European Commission and other authorities are expected to differ from each other in some points, GDSN will allow labelers to maintain a single comprehensive dataset to manage and update their device product data with FDA and around the globe for efficient and effective healthcare.
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