Knowledge Center

The AHRMM LUC members submitted comments and recommendations to the FDA's Draft Guidance for Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices. They recommend that information related to all Class I Medical Devices be included in the GUDID without exception.

The UDI-DI Change Communication Process Work Group, a part of AHRMM's Learning UDI Community (LUC), recently released a report analyzing current communication processes and their implications on all stakeholders related to changes to the UDI-DI. Gain a clear understanding of how these changes are documented in affected software systems, identify gaps between current and desired states, and develop recommended practices to improve the process for all stakeholders.

The UDI Impacts on Recall Management Work Group, a part of AHRMM's Learning UDI Community (LUC), has released their recommended practices reports that analyzes the barriers and highlights the benefits to patient safety and key stakeholder groups when utilizing the UDI throughout the recall process. Work group members identified recommended practices for each of these groups underscoring mutual areas for improvement in the safety and efficacy of the recall process. In addition to the two Impact Reports, there is also a comprehensive Regulatory Resource Guide and a Supporting Information document with detailed reports, resource links, surveys and summary presentations that the work group members created, as well as a Recall Time & Cost Collection Tool.

The AHRMM LUC members submitted public comments and recommendations at the FDA's November 2020 meeting related to the need to include the UDI in the recall process. They highlighted the prototype recall database and electronic submission form, as well as survey data supporting its creation.

In September 2019, FDA announced its Technology Modernization Action Plan (TMAP).  The TMAP describes important near-term actions that FDA is taking to modernize use of technology—computer hardware, software, data and analytics—to advance FDA’s public health mission. The TMAP will provide a foundation for developing a more fluid, agile, and efficient FDA that is scaled to respond to novel technologies and a rapidly increasing workload.

Read this report on the recommended practices related to the allocation of multiple unique device indicators (UDI-DI) and suggested ways to mitigate the occurrence or negative implication of multiple UDI-DIs. Download Report