As the first deadline for compliance with the U.S. Food and Drug Administration final rule on Unique Device Identification (UDI) swiftly approaches, medical device manufacturers are learning just how vital it is that their UDI data submissions are accurate.
The manufacturers of most Class III medical devices must comply with the FDA’s final UDI rule by Sept. 24, 2014. That deadline includes successful data submission to the FDA’s Global Unique Device Identification Database (GUDID). Though Class II manufacturers have more time in which to prepare, many in the medical device industry are watching the Class III process to learn best practices for successful compliance.
One critical component of a successful FDA UDI compliance program is choosing a GUDID submission service with robust data verification capabilities and software that will ensure the final submissions are accurate. As you might expect, accuracy of the final GUDID submission is the most important attribute of any GUDID solution, according to eight out of 10 medical device manufacturers surveyed for Reed Tech earlier this year.
While this is a new area for many vendors that now are promoting UDI solutions, it is familiar ground for Reed Tech and its GUDID Submission Solution. Reed Tech has worked closely with the FDA regarding its Structured Product Labeling submissions and technical requirements since the 2005 mandate of pharma SPL submissions, and understands the value and importance of accurate submissions that meet the changing FDA regulations.
Earlier this year, Reed Tech volunteered to work with the FDA in a pilot program, making thousands of test submissions to the GUDID. That gave us valuable experience from which our medical device manufacturer customers are now benefitting.
To date, we have successfully made thousands of GUDID submissions on behalf of our many Class III customers. Due to our deep experience, the GUDID data we have submitted on behalf of our customers has been accepted quickly and cleanly.
The data verification routines built into our GUDID Submission Solution alert manufacturers when their data contains information that is non-compliant, and flags the data with an error message(s) so it can be corrected before submission to the FDA.
For example, the Reed Tech GUDID Solution can detect when optional fields are necessary for submission. One of these optional fields is the Unit of Use Device Identifier (UoU DI) which is required only when the Base Package Device Count is greater than one. When the UoU DI is required, the Reed Tech GUDID Solution verifies that 1) a UoU DI value is included in the data record, 2) the UoU DI is from the same issuing agency as the Primary DI (GS1, HIBCC, or ICCBBA) and 3) the data conforms to the format rules.
Reed Tech customers benefit not only from the data verification measures built into the Reed Tech GUDID Solution, but also from our subject matter expertise in understanding the necessary data attributes for submission. Customers may contact a Reed Tech subject matter expert at any time for assistance in understanding how to create, collect and supply these necessary data attributes.
Additionally, the Reed Tech GUDID Solution can perform a number of controlled vocabulary transformations. The FDA will fail a GUDID submission if the data attributes do not meet its strict controlled vocabulary terms. For example, a medical device manufacturer may have “centimeter” designated as a length unit in its internal database, however the FDA will only accept the value “cm” under its controlled vocabulary terms. The Reed Tech GUDID Solution can transform data attributes, e.g., transform “centimeter” to “cm,” to ensure the data record is successfully received and published at the FDA GUDID.
Working with the FDA for SPL submissions is new to many companies offering UDI FDA “solutions” and they may miss some of the myriad technical requirements of the UDI rule. The subject matter experts at Reed Tech Life Sciences have years’ worth of experience in perfecting data submissions to the FDA which helps explain our stellar track record for GUDID submissions.
GUDID submissions must meet comprehensive FDA compliance rules and be accurate. To find out more about how the GUDID Submission Solution from Reed Tech can help your company achieve accurate UDI compliance, contact us today.