UDI for Medical Devices Work Group

The UDI  Work Group was formed to assist with the implementation of auto ID in these regulated environments. The committee is comprised of veterans of the industry, each with several decades of experience. Some of the committee members have been involved in the auto ID industry since its infancy; all are current practitioners in one aspect or the other.

​The work group constructed a News Release accompanied with the Digital Supply Chain Whitepaper to assist organizations in understanding how AIDC technologies and standards are being used to ensure traceability for all lines of devices especially during COVID times. 

Read our comments to the FDA:

• Draft Guidance for Transition Plan for Medical Devices Issued Emergency Use Authorization (EUAs) during COVID. 
• Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices. 

UDI Resources

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U.S. FDA UDI Regulations Turns 10

Read the full article here. 

Goals

• Leading appropriate technology recommendations in both bar code and RFID to implement healthcare standards in North America
• Accurately communicating
  • Lessons learned from past serialization efforts and industry best practices
  • Relationships of UDI  initiatives
  • AIDC technology (hardware, software) to support implementation
  • Return On Investment (ROI) from every perspective
• Creating a forum for open discussion of industry and FDA adoption issues
  • LinkedIn UDI Group, with over 3000 members​

Seminar - The Pulse of US UDI Implementation and Global UDI Impacts

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An anniversary marks the occasion to look back and review successes, and to look to the future to identify areas that provide a platform for expansion, improvements and opportunities. The 2023 AIM UDI Seminar will commemorate the 10-year anniversary of the release of the US FDA UDI Rule and the proliferation of UDI-related activities globally. Successes to date achieved through the dedicated efforts of all the industry stakeholders will be acknowledged and some of the challenges and issues yet to be resolved will be discussed as we move past this first decade of implementation.

Agenda

​US FDA’s UDI: Ten Years of Success and What’s on the Horizon
Indira Konduri, Deputy Director, Division of Regulatory Programs 3 (DRP3), Center for Devices and Radiological Health (CDRH), U.S. Food & Drug Administration 

Unresolved Issues Impacting Implementation
Kevin Capatch, Director of Process Engineering, Geisinger Health System

Reflections on Achievements and Opportunities for Future Expansion
Jay Crowley, VP of Medical Device Solutions and Services, USDM Life Science; Dennis Black, UDI Program Director, BD;
Natalia Wilson, Executive Director, Center for Healthcare Delivery and Policy, Arizona State University and Adjunct Assistant Professor, Mayo Clinic Alix School of Medicine

​Ask The Experts Open Q&A with Speakers