UDI Work Group Comments to the Centers for Medicare & Medicaid Services and FDA Reinforces Shared Commitment to Patient Safety

​AIM North America’s position is brought forth by the members of the UDI Work Group. The Group's letters are in direct support of comments submitted by the GS1 US to the FDA and Centers for Medicare & Medicaid Services as it relates to UDI for Medical Devices.
 
The UDI Work Group brings together a dedicated coalition of manufacturers, distributors, hospitals, and industry stakeholders to advance compliance and best practices. Jay Crowley, UDI Work Group Chair emphasized that “We stand ready to support the Centers for Medicare & Medicaid Services and FDA in navigating technical AIDC requirements, ensuring robust standards and seamless implementation.”
 
“Supporting open standards, AIM North America empowers organizations to leverage asset intelligence. Our focus on traceability provides vital safety checks and accurate device visibility at the point of care,” explained Mary Lou Bosco, President, AIM North America.

1 ) Centers for Medicare & Medicaid Services Ensuring Safety Through Domestic Security with Made in America Personal Protective Equipment (PPE) and Essential Medicine Procurement (CMS-2026-0298)

2) FDA Recall Enterprise System

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