By now, most device makers have begun to identify how the FDA’s final rule on Unique Device Identification (UDI) will impact them. All devices, regardless of class, must be catalogued and identified for inclusion in the Global Unique Device Identification Database, or GUDID.
Most device companies have started assembly of medical device UDI data, and many are discovering that GUDID submission will require more resources and IT capabilities than they are able to provide in-house. For leaders of those companies tasked with UDI compliance, the key question now is “How do I choose the right UDI solution provider?”
We advise finding a vendor with proven practical SPL and GUDID submission experience. Early on, working toward GUDID compliance was a new challenge for everyone, but with the deadlines looming, you don’t want your GUDID project to serve as on-the-job training for your vendor, no matter how strong their other technical qualifications.
Following is a list of criteria you can use to measure your prospective vendor’s suitability for your GUDID submission project:
Can a vendor’s solution “stage” your data?
From small device manufacturers with a small number of submissions to large device makers with enterprise IT teams focused on UDI, data that eventually populates the GUDID entry may be collected from widely disparate parts of an organization. It’s possible that some of these groups have not previously had occasion to share information until GUDID compliance efforts began.
Any product or part that requires GUDID compliance may require the coordination of data that arrives at different times, in different formats, from different operational environments. With all these different paths, data may travel through a “staging” area before the data becomes integral to successful submission of both assembly of individual device records and your organization’s final GUDID submission. Each product entry will have a set of data fields from the manufacturer, followed by the GUDID’s generation of another set of data that will be combined in the final record. The best UDI and GUDID solutions will have been designed with this workflow in mind.
The best solutions will offer the flexibility to add or customize data fields that supplement the fields specifically required by the FDA, such as a field for an internal product or catalog number.
The importance of auto-validation capabilities
No matter how good a candidate the GUDID assembly solution may appear, the collected data must ultimately be confirmed to be error-free. The last thing a device manufacturer wants to do is send bad data to the FDA. In a well-designed GUDID submission solution, most of this error-checking will be performed by the software with human intervention only where needed. Final pre-submission approval of the organization’s aggregate GUDID information, for example, should not be solely automated but should have human oversight to ensure data accuracy.
In most organizations, the bulk of data errors are typically introduced during some phase of data entry, and a proven error-checking and correction routine in your vendor’s GUDID solution will detect and correct these errors prior to submission to the FDA. Your vendor’s software solution should further be able to detect SPL data errors introduced by malformed code, such as a missing or broken XML tag.
If your vendor’s system doesn’t offer solid error correction for both entered data and SPL assembly , these errors will need to be found and fixed manually, demanding time and resources and introducing additional opportunities for errors in your collected data.
Acknowledgement after submission
Once your GUDID data has been electronically submitted to the FDA, the system you use will receive electronic acknowledgement back form the FDA describing the success or failure of your submission. If the submission fails, the response from the FDA system will include coding that details the specific reason or reasons for the failure.
Your vendor’s solution should be designed to receive, interpret, and act on these automated acknowledgements from the FDA. A well-designed GUDID solution needs to be able to translate the sometimes cryptic coding in the FDA acknowledgement into a readable report that clearly guides you on how to fix any errors in the submission.
After your successful GUDID submission, your company’s GUDID data will remain a living informational asset that will require maintenance. Medical Devices evolve as technology and ownership of business units and product lines changes. The GUDID software solution you select now will probably be with you for years, and as such, should provide your organization with the ability to modify, import, export, transfer, or delete records from the system.
GUDID isn’t the only compliance requirement
Most organizations working to comply with GUDID already are familiar with 21 CFR Part 11 (“Part 11”), the set of federal regulations that govern electronic records for Life Sciences companies. Part 11 requires strict accountability regarding access or changes to databases and other electronic resources involved in the production of regulated products. GUDID is no exception, so you must require 21 CFR Part 11 certification for any vendor involved in your GUDID project, as well as for any software package they include in their proposal.