Regulatory Open Forum

Anyone had experience w/ the GS1 process? One of our private label clients is asking about how the process works, timeline, etc. I've actually never applied before. I feel that this should be something that would be better done by the company distributing the product, but any insight is much appreciated. Thanks.

I assume the context is UDI.

One of the UDI questions is who has the responsibility to implement UDI. The company putting the device on the market is responsible for UDI. One easy way to determine this is the company name on the label. I infer that in a private label situation it is the customer.

UDI has the potential to reconcile many of these relationships. I infer your customer is registered with FDA as a Specification Developer and you are registered as a Contract Manufacturer. In this situation, the Specification Developer is responsible for UDI.

For UDI, there are three top level aspects: updating the QMS, which should have been completed by Dec. 23, 2013; labeling the device and all the packaging configurations; loading the data into GUDID. The second two depend on the Compliance Dates.

GS1 has a lot of information on their website. I have a number of clients that use GS1 for the labeling information. It appears straight forward but, for some companies, expensive.