The U.S. Food and Drug Administration is proposing that many manufacturers implement a unique device identification (UDI) marking system. This change will require manufacturers to make expensive changes to their packaging line. This proposal is a response to a 2007 mandate. However, manufacturers have been criticizing the key elements of the proposal, requiring the FDA so reconsider specifics. The FDA UDI requirement would apply to the direct marking of devices and their packaging for Class I, II, and III devices. Medical device manufacturers will be able to use one of two established tagging protocols, either those established by the international standards organization called GS1, or those approved by the Health Industry Business Communications Council (HIBC). Both of those groups will have to apply to the FDA to be accredited before their tagging systems are deemed acceptable. Even manufacturers that are “ahead of the curve” with device labels that meet the HIBC or GS1 GTIN standards would have extensive packaging line remodeling in front of them.

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