Pulling information out of the FDA GUDID is simple. The public can access information contained in the GUDID through AccessGUDID. The FDA, in partnership with the National Library of Medicine (NLM) has announced that through AccessGUDID, anyone can search or download information that device labelers have submitted to the GUDID about their medical devices. GUDID submission options, however, is an area in which a few options present themselves.
GUDID Submission Options
#1 – GUDID Web Interface
A free secure online portal known as the GUDID Web Interface is provided by the FDA and it enables medical device labelers to enter UDI data directly into the GUDID database. Device labelers may submit, search and retrieve information about their devices via the GUDID Web Interface, which enables structured input of information one DI record at a time. A few caveats though, if data is entered using the GUDID Web Interface, it must be managed using the GUDID Web Interface. This portal is most practical for companies with <100 different SKUs or catalogue items. A number higher than that requires a more robust approach.
#2 – Software as a Service (SaaS)
The vast majority of GUDID submission offerings that are available in the market today, fall into this category. These cloud based offerings create data silos between your enterprise based systems and a third party. They also create a need for setting up and maintaining multiple connections between your enterprise systems and your product labeling systems. Introduction of errors caused by data getting out of sync between labeling and upload systems is a very real possibility. Proving auditable history for 21 CFR Part 11 compliance and potential trace history is more complex when some of the history resides in the cloud and some of it resides in other systems. In many cases, cloud based technologies have the capacity to reduce complexity. However, when it comes to regulated data upload and management, SaaS greatly compounds complexity. The outsourced service model offered by some SaaS providers is merely a way to pay a third party for some of the increased complexity that their business model creates.
#3 – Licensing A System
Systems are available from a few providers and Innovatum provides the most complete, end to end UDI solution in the industry. Although the complete suite of Innovatum’s ROBAR product line includes the option of labeling design and print management capabilities we are limiting this article to a focus on regulatory data upload. Suffice it to say that with this solution, the same database and corresponding connections to existing production and business systems (PLM, MDM, ERP, RA, etc.) can be used for both labeling data and the upload and management of regulatory data. This also means that one approval management system can be used for both labeling data approval and regulatory upload data approval. This remarkably reduces approval management overhead for medical device manufacturers and relabelers such as 3PLs and contract manufacturers. The ROBAR master data management and communication components are intended to be licensed as an on-premise solution for companies that desire tight control of their data. However, the solution can also be deployed in the cloud very easily. ROBAR MDM is a focused master data management database that is specifically designed for regulatory data. It serves as a real-time conduit for regulatory data that coalesces information from various sources and maintains the history of that data in a 21 CFR Part 11 compliant manner. The one-time licensing fee and annual maintenance costs for this technology winds up being much more cost effective than SaaS or service based per transaction, per item, per company revenue models.