October 31, 2014
The Food and Drug Administration (FDA) reported that there have been over 240 user accounts set up in the agency’s Global Unique Identifier Database (“GUDID”) since the rule’s effectiveness date. From those accounts, over 33,000 Device Identification numbers were entered into the GUDID. This was identified as a very good start by agency personnel at the 6th Annual UDI conference this week in Baltimore.
Class III Device Compliance: First UDI Deadline Passed
The deadline for all Class III Medical Device manufacturers has now passed. The agency thanked those that have worked so hard to get in compliance by last month’s due date. Additionally, it shared updates and lessons learned over the last 13 months. These were since the rule was finalized and released.
Upcoming Deadlines for Class II Life-Sustaining and Implant Devices
The clock now starts ticking for manufacturers (FDA uses the term “labelers”) of Class II devices. These devices are implants, life-sustaining, or life-supporting in nature. These labelers must complete their UDI implementation and enter their device information into the FDA’s GUDID by September 24, 2015.
However, the FDA said that the labelers of these Class II life-sustaining/supporting devices will not be granted user accounts until January 2015, at the earliest. This does not mean that this group of manufacturers should stand around doing nothing, though. There are many preparatory and investigatory activities that this group should begin actively moving forward on. Some of these activities include developing a project team and reviewing current labeling processes and artwork. Furthermore, they should identify/obtain a DUNS number (if one is not currently defined for the labeler). Most importantly, ensure upper management is aware and fully supports the UDI initiative in their organization. This is crucial in order to drive internal commitment and resources.
Compliance Timeline for Class II and Class I Devices
Attendees were also informed that all other Class II devices must be in compliance by Sept 24, 2016. Furthermore, all Class I devices must comply by Sept 24, 2018. Unfortunately, if the current practice remains in effect, those labelers in these two other groups will not be given account access to make any submissions until late 2015 or early 2016. For now, the FDA will focus only on Class III and Class II implants/life-sustaining/life-supporting labelers.
FDA UDI System Updates and Public Access Changes
Other topics during the conference included recaps of the UDI Rule and the GUDID system. One interesting update: The FDA’s UDI web interface will no longer be available to the public/healthcare workers for direct access and searching of the GUDID for medical device information. FDA’s UDI group has recently partnered with the National Library of Medicine and will be integrating the GUDID with the NLM’s online system for public searches. This will include database downloads and web service access to medical device information stored in the GUDID. This will reportedly be available 1st Quarter of 2015.
UDI Extensions and the Importance of Early Preparation
Although the first phase of UDI compliance with Class III labelers has been deemed successful, it was reported that several dozen extensions have been provided to members of this group. However, the FDA hasn’t said if extensions will be granted to Class II or Class I labelers, as well. So, if you haven’t already, it is in your best interest to start your UDI project soon.
Next Steps for UDI Record Management Solutions
If you are interested in seeing a low-cost solution for UDI record management that provides electronic submissions to the GUDID and integration to other quality processes, such as complaints management, please request a demonstration.
