Coalition endorses GS1 systems for unique device identifiers
This article was originally published in The Silver Sheet
Executive Summary
The Healthcare Supply Chain Standards Coalition has endorsed the global organizational and product identifier systems of the international standards organization GS1. Because the coalition's oversight committee includes FDA, Abbott, Johnson & Johnson, Cardinal Health and the American Hospital Association, the endorsement likely means that FDA's independent system for unique device identifiers (UDIs) will rely on GS1's systems. The creation of a UDI system was one of the top recommendations made by CDRH's Postmarket Transformation Leadership Team in last year's report, and was mandated by the recent FDA Amendments Act ("The Silver Sheet" October 2007)