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.


FAQ

What is UDI?

UDI stands for Unique Device Identification. This term is used to describe the identification of medical devices.

What does the US FDA UDI rule mean?

It covers several classes of products sold in the United States and includes requirements related to the identification of medical devices, data collection from barcodes, and item information to the FDA’s medical device database.

Why do you need to know this?

As part of the UDI Regulation in the US, GS1 is one of the accredited issuing authority. This requires us to store information about companies that use GS1 standards to assign UDI to their products that are sold in the United States. This information needs to be reported regularly to the US FDA.

What happens if I do not know if my products are covered by this regulation?

If you do not sell products in the United States, the regulation does not apply to you. However, it is possible that someone else will sell them there after buying them from you. Therefore, you need to confirm whether your product is classified by the FDA as medical equipment.

If I say yes, what information do I share with the FDA?

We share your company name, business address, and GS1 company prefix or individual GTIN numbers assigned to you. The contact name will not be disclosed unless requested by the FDA.

What are the consequences of saying no?

If your product is not sold in the United States as medical equipment, there will be no consequences. If you have a product or products sold in the United States and they are classified as medical devices, please answer yes. If we have not shared your information and GTIN with the US FDA, there may be problems with your medical devices that are already on the US market.

If I answered no but later promoted medical devices in the US, should I update my response?

Yes, you must ensure that this information is maintained regularly so that we can keep the reporting to the US FDA as up to date as possible. If you need to update your response, please contact customer service.