Member declaration US FDA Unique Device Identification (UDI) rule
What is UDI?
UDI stands for Unique Device Identification. This term is used to describe the identification of Medical Devices.
What is the US FDA UDI ‘rule’?
This is in fact a regulation from the United States Food & Drug Administration that sets out how products classified as medical devices are regulated and can be supplied within the US. It covers multiple classes of products sold within the US and includes requirements related to identification, data capture and master data requirements.
You can learn more about this regulation here.
Why are you asking me about it?
As part of the US UDI regulation GS1 is one of the accredited issuing agencies. This requires that we maintain information of companies that use the GS1 system for assigning UDI to their products where they are sold within the US. This information is required to be provided to the US FDA on a regular basis.
What if I don’t know if my products fall under this regulation?
If you don’t sell products in the US, they don’t. However, it is possible someone else sells them there having purchased them from you. Therefore, you will need to confirm whether your product is classified by the FDA as a medical device. You can learn more here.
If I say yes, what information about me do you share with the FDA?
We will share your company name, your business address and the GS1 company prefix or individual GTINs you have been allocated. No other information about you will be provided.
What are the implications of saying no?
If your product never appears in the US as a medical device, there are no implications. If you have a product, or products sold in the US and they may be classed as medical devices then you must answer yes. If we have not shared your information and identifiers with the US FDA there may be issues in your ability to market your products in the US.
Once I give my response, is that the end of it?
No, you need to ensure that this information is maintained regularly so that we can keep the reporting to the US FDA as current as possible. If you need to update your response, please call our Customer Support team on 1300 BAR CODE so we can make the update for you or once available you will be able to update in your MyGS1 account.