HIDA Government Affairs Alert

April 26, 2016

Single Use Devices (SUD) and Convenience Kits Led

UDI Conference Discussions

April 18–19, HIDA sponsored and participated in the annual FDA-led Unique Device Identification (UDI) conference in Baltimore. Key takeaway presentation links and GUDID account signup are listed below.

Topics of particular interest to HIDA’s member constituency were a large part of the conversation. As industry looks toward the Class II and Class III deadlines, discussion around how the supply chain interprets the term “unit of use,” repackaging and who is ultimately responsible for applying the UDI and entering the information into the Global Unique Device Identification Database (GUDID). The FDA stressed that any company whose name is on the label must have a GUDID account regardless of who manufactured the item. Additionally, the FDA led a session devoted solely to entering convenience kit “device types” and Single Use Devices into the GUDID.

This year’s agenda focused on the looming September 24, 2016 deadline for UDI labeling compliance of Class II medical devices. Much of the discussion over the course of the two days focused on lessons learned and UDI adoption hurdles from the perspective of both the FDA and affected labelers of Class III and implantable, life-supporting, and life-sustaining devices, who had to meet the identifier regulations in 2014 and 2015 respectively. Additional discussion from the private sector included how health systems and hospitals have/intend to prioritize UDI integration and how to transmit UDI among electronic health record systems.

The FDA led various discussions on submitting device identifier “DI” information into the GUDID. The agency ensured attendees that it continues to make updates and improvements to the GUDID system in advance of the Class II deadline, as many in audience expressed concern with the amount of data that is expected to be entered due to the large number of Class II devices in the supply chain. The FDA encourages all new Class II labelers to request GUDID accounts ASAP.

HIDA continues to be engaged with the FDA and various supply chain industry stakeholders on the single use device/unit of use issue, as well as, the impact of UDI compliance on members to assemble convenience kits. Future updates on this front will be forthcoming.

►Download 2016 UDI Conference presentations

►See HIDA’s April 2016 comments to the FDA on Medical Convenience Kits

►See HIDA’s Infographic on Single Use Devices and Distributors

For questions regarding UDI and HIDA’s efforts, please contact Amy Kohl at 703-838-61213.