Data Submitted! But the UDI Journey Continues...

October 31, 2016 Daniel Henrich

September 24 and the Class II UDI compliance date is past. Hopefully, you met the deadline and all of your records are now published and visible in Access GUDID, the public’s window into the GUDID database. But UDI is not over. In fact, for medical device labelers, it will always require maintenance and ongoing work. UDI is the new normal.

So, what is your organization’s plan for maintaining all that data going forward? After your UDI task force turns its attention to other projects, how will you ensure that new products or updates get submitted to GUDID and that old records are retired?

On the other hand, how do you now sync all of your GUDID data back to your internal systems to make sure the data on file with FDA exactly matches your own records? Remember, your UDI records in the GUDID constitute FDA’s records about your product portfolio, so it is crucial that GUDID is populated with all of the same data as you have on file internally.



An excellent approach to tackling this problem is to regard and use GUDID data as your master data set. Consider implementing a procedure whereby you sync data values stored in internal systems to those in the GUDID.

If you have chosen to submit via the FDA’s Web Interface in order to meet the deadline, consider how you will keep those records up to date and in sync with your own databases and tools. You may find that SPL is a worthwhile investment going forward, even though the Class II UDI deadline is past.

If you have questions about how you can maintain up to date UDI records with FDA and align these values with your internal systems, please register for our upcoming webinar on November 15. Reed Tech UDI subject matter expert John Lorenc will be discussing UDI post-submission responsibilities and showing labelers how they can leverage their investment in UDI data to deliver value after submission.

Previous Video
REMS in SPL Webinar
REMS in SPL Webinar

SPL expert Gary Saner discusses the FDA's new initiative to receive Risk Evaluation and Mitigation Strategy...

Next Article
Five Things to Look for in Choosing a Full-Text Patent Research Solution
Five Things to Look for in Choosing a Full-Text Patent Research Solution

Need additional information?

Contact Us