UDI Labeling Requirements

We are a manufacturer in the U.S. planning on launching new products specifically for the EU. From what I understood from the UDI Final Rule, products to be exported from the U.S. are exempt from UDI Labeling requirements. We currently have thousands of UDI compliant products with UDI compliant labels. I was wondering whether we can move forward with using these UDI compliant label template for the exempted products. The only difference in the exempted products to be sold in the EU, is that the label wont contain the DI number, since the information regarding these products wont be submitted to the GUDID system. Is this reasonable or would it be considered fraudulent to use these existing UDI compliant label templates?

 

Hi, there is no problem having additional information on the label. Assuming the DI information still accurate, even though its not submitted to GUDID, there is nothing to sop it being present on the label.

We are adding 2D, UDI compliant, barcodes to all our products, whether or not they are going to be listed in USA. It means we have a common template and less likelihood of mistakes.

Chris

 

Hi Chris,

Thank you for that reply. I was under the impression though that we shouldnt be using or including the Primary DI Number on the labels of exempted products since they wont be submitted to the GUDID. Is this correct? I was thinking that the only difference between the product labels that we have submitted in the GUDID and the products that we are not going to submit is that, the exempted products' labels wont contain the Primary DI Number. I was thinking that the primary DI number wont be necessary since it wont be searchable in the GUDID system anyways. Please let me know what you think.

 

The DI (Device Identifier) contains the GS1 GTIN number for a product from your company (GS1 or similar from another agency). If you are using UDI and have registered with GUDID, then you have to include the DI. However there is nothing to stop you using the DI in any other barcode for any other purpose. As an example, we have always had a 1D barcode on our products with the DI information which was used for stock control and shipping.

If you are not going to register your products with GUDID, then you don't need a DI, but there is nothing to stop you using one.

Chris

 

Hello,

I am not sure where to go to open a new post. I need some help re: UDI and the recent FDA ACE/Customs and Border Patrol program. I am working on UDI for US product.

We have a US warehouse where we receive product for export (we receive from our plants in Japan or China). We hold product and then ship to other countries outside of the USA-none of the product is distributed in the US.

There has been much discussion as I was told I need to apply UDI to the product even though it will not be distributed in the US. I then had to enter into the GUDID. We were told that import for export must comply with FDA regulations. Does anyone have experience with the ACE program and how import for export is required to be labeled with UDI and entered into GUDID. This makes absolutely no sense to me and I can not find anything anywhere that describes this situation.

Thanks in advance for your help

 

Sorry, I dont have any experience with ACE or "Import for Export". However you could email the FDA UDI Helpdesk.

http://www.fda.gov/MedicalDevices/D...ance/UniqueDeviceIdentification/ucm368904.htm

Chris