Achieving Success for UDI Rule

• Karen Conway, Vice President, Healthcare Value

Do you think your data is ready to submit to the Global UDI Database (GUDID)? What will you do if your submission fails? Do you know how you will archive communications with the U.S. FDA?

At its core, UDI requires a new way to organize, synchronize and distribute data. Manufacturers have to consider how their product data will be used through distribution and use. Gathering and preparing data has its own unique set of challenges.  You also need to understand the communication (acknowledgements) received from the FDA after your data is submitted. Additionally, an archiving method for all communication sent and received must be developed.

Think about the systems and processes needed to comply with the UDI rule from many perspectives.  How will the data ultimately be used and by whom?  Stepping back to see the bigger picture is important for success.

Following are two tactical capabilities related to GUDID data submission success:

One: Ability to Decipher Errors on Acknowledgements

Even with careful preparation, there are bound to be occasional errors in your data submission. The FDA has already had several changes in data attribute requirements and there will be more. Formatting of certain data can be a stumbling block. The submission must line up perfectly with the GUDID requirements or you will receive an error acknowledgement such as the one below.

The error message needs to be deciphered and corrected before resubmitting the data.

Two:  Archive Each Transmission

Every submission should be individually tracked and associated with acknowledgements. The archiving system is responsible for the submission data, the human readable representation, and acknowledgments as they become the revision controlled UDI regulatory record for that product.

Karen Conway

Vice President, Healthcare Value