FDA Applauds GUDID Progress, Eyes Class II Compliance Efforts
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, and from those accounts, there have been over 33,000 Device Identification numbers 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.
The deadline for all Class III Medical Device manufacturers has now passed and the agency thanked those that have worked so hard to get in compliance by last month’s due date. It also shared updates and lessons learned over the last 13 months since the rule was finalized and released.
The clock now starts ticking for manufacturers (FDA uses the term “labelers”) of Class II devices that 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, FDA said that the labelers of these Class II life-sustaining/supporting devices will not be granted user accounts until January of 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, reviewing current labeling processes and artwork, identifying/obtaining a DUNS number (if one is not currently defined for the labeler), and most importantly, ensuring upper management is aware and fully supports the UDI initiative in their organization in order to drive internal commitment and resources.
Attendees also were informed that all other Class II devices must be in compliance by Sept 24, 2016, and all Class I devices by Sept 24, 2018. Unfortunately, if the current practice remains in effect, those labelers in these other two groups will not be given account access to do 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.
Other topics during the conference included recaps of the UDI Rule and GUDID system. One interesting update: the FDA’s UDI web interface will no longer be made available to the public/healthcare workers for directly accessing and searching 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, database downloads, and web service access of medical device information stored in the GUDID. This will reportedly be available 1st Quarter of 2015.
Although the first phase of UDI compliance with Class III labelers has been deemed successful, it was reported that there have been several dozen extensions 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.
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.