New legal requirement for medical devices

There is a new legal requirement from the Food & Drug Administration (FDA). It concerns suppliers who use the Global Trade Item Number (GTIN) for their medical devices classified according to Unique Device Identification (UDI) and are sold on the US market.

More and more countries are adopting laws requiring companies that manufacture, label or distribute medical devices to identify them with a Unique Device Identifier (UDI). Important information to know is that a GTIN (Global Trade Item Number) issued by GS1 Sweden can be used as a UDI in several countries and areas such as the US.

What is the US FDA UDI rule

It is a regulation that describes how devices classified as medical devices are regulated and can be supplied in the United States. It covers several classes of products sold in the United States and includes requirements related to identification, data collection and item information.

GS1 holds power of attorney as an issuing body for UDI by the FDA (Food & Drug Administration) in the United States. This means that GS1 is required by law to annually disclose which companies use GTIN to assign UDI to their products that are sold in the United States. This information is regularly required by the US FDA.

Read more on our UDI page