Next UDI Deadline Will Place Stress on GUDID Database

by Maureen Perroni, on July 18, 2016


The next major deadline for UDI implementation isn't until September 24, 2016, when Class II medical devices will be required to comply with the rule and be submitted to the Global Unique Device Identification Database (GUDID). But the FDA is still hard at work preparing for this latest chapter in the long-running effort to ensure that all medical devices are clearly labeled.

"Though there are already 150,000 records in the GUDID, this number could increase significantly after September."

One important question the FDA must consider is whether the digital infrastructure of the database can support the expected number of reports. Currently, the agency is conducting performance and load testing to ensure that the high volume of traffic will not overwhelm their system, according to Healthcare Dive. Though there are already 150,000 records in the GUDID, this number could increase significantly after September, and failure to keep the database online could hamper the continuing rollout of UDI regulations.

Under the UDI, the first medical devices that became part of the database in 2014 were Class III, or high-risk, devices. These include implantables, such as pacemakers. Only 10 percent of medical devices fall under this category, according to the FDA. Class II encompasses a much broader category of devices that makes up about 43 percent of the total. These include items for external use, such as pregnancy test kits. This means that a much larger proportion of devices will soon enter the GUDID.

While the FDA is in the process of stress-testing its database, device manufacturers have their own preparations to make for the upcoming regulatory deadline. Now that they are dealing with a greater variety of devices, makers have their work cut out for them to ensure that each one is clearly and accurately labeled. The increasing complexity of the UDI rollout demands an Enterprise Labeling Solution that can meet manufacturers' specific labeling needs.

To find out more register for our live webinar "Taking the Pulse of UDI Compiance," on July 21st with industry expert Jay Crowley.

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Topics:Medical Devices