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Labeling or Data Submission, Which UDI Step Comes First?


When I speak to medical device industry members about the FDA’s requirements for submitting their UDI data to the GUDID, I am frequently told they are not worried about that aspect yet. I often hear, “We are just focusing on getting our labeling completed at this point then we will submit to the GUDID at the end.” I can save them a lot of trouble in the long run when I hear this type of comment by sharing a very important insight. I usually begin by telling them about a Reed Tech customer who took the same approach, completing labeling first and worrying about data submission afterwards.

When they came to Reed Tech last year, our customer had a good understanding of UDI requirements and had already taken many of the necessary steps to implement a successful UDI program. They had already taken care of all of their labeling obligations, right down to printing and applying the new labels. They realized the data submission aspect of UDI was something they needed help with, so they came to Reed Tech.

All went smoothly collecting their data, then the time came to begin actually making their submissions to FDA. At this point, they realized there was a problem. An error had occurred in the calculation of the check digits for their GTIN Device Identifiers. It was a simple mistake that could be easily overlooked in all of the preparations necessary to implement UDI, but the consequences were profound. Their labeling had already been finalized, printed and applied to some of their product bearing the incorrect check digit in the barcode and human readable sections of the label. Only when they encountered errors submitting their records to the FDA did this become apparent. The necessary course of action to correct this simple mistake was both discouraging and expensive—revise, reprint and reapply the labeling for every affected device in their portfolio.

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This is just one example of how things can go wrong late in the process. Consider also that any time a non-editable field in a UDI data record needs to be changed, a new Device Identifier (DI) is needed, meaning a new data record submission and a change to the content of the device label.

So what can device labelers do to mitigate the risk of something like this happening in their organization? The good news is that you can implement a simple best practice for UDI: do not finalize and print your labeling until you have successfully submitted your data records to the GUDID and they have been accepted by FDA. Please note that this does not mean you cannot start on your labeling until GUDID submission is complete. You can work on these projects in tandem, but you should use the GUDID submission process as a final check on the quality of your data prior to finalizing your labeling.

Partnering with Reed Tech can help. The Reed Tech UDI system implements a number of checks on data prior to submission to make sure records fit the format requirements of the FDA. It also helps you to monitor the status of your record submissions and quickly address any errors that occur.

Contact Reed Tech today to talk with us about how you can approach UDI in a way that minimizes the risk of errors and costly mistakes. We will be happy to help.


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