Last week, device manufacturers, FDA representatives, service providers and other medical device industry members met in Baltimore for the 2015 Unique Device Identification Conference hosted by The Clarion Group. This was a great opportunity to hear from experts in different areas of the device industry about various topics related to UDI and to compare notes with colleagues who are working to comply. In case you were unable to attend, the Reed Tech team has compiled the following highlights from the conference sessions by Linda Sigg and Indira Konduri of the FDA.
Growing GUDID Activity
The number of Device Identifier (DI) records in the FDA’s GUDID database increased from 33,000 in October 2014 to over 75,000 in June of this year. The number of GUDID labeler accounts increased during the same time period from 240 to 425. This increased activity triggered over 4,000 additional Help Desk Tickets; FDA responded with a 95% ticket closure rate.
The plan is currently for the FDA to allow Class II manufacturers to set up GUDID accounts beginning in January 2016. This will allow the FDA to assist those with the most pressing deadlines—manufacturers of Class III and Implantable, Life-Sustaining and Life-Supporting devices—to achieve compliance prior to the anticipated Class II rush.
The FDA confirmed that labelers may edit their Published GUDID records via either submission method (HL7 SPL or Web Interface).
Common Issues and Clarifications
There remains uncertainty surrounding the question of who is the labeler of a particular device. The short answer is that the company whose name is on the label should be considered the labeler.
The most common issues with the records submitted to the GUDID were:
- Primary DI number typos
- Package DIs entered as Primary DIs
- Package DIs associated with wrong Primary DIs
- Records with incorrect publish dates
In light of these common issues, the FDA speakers encouraged device labelers to implement record management SOPs.
These are, of course, only a handful of the topics discussed during a very valuable two-day conference. Slides from other great presentations are available for download here. As always, experts from the Reed Tech team are happy to speak with you regarding these or any other UDI topics you would like to discuss.