GS1 Healthcare issues UDI guidance

Supply chain standards development organization GS1 Healthcare US has released guidance for using certain standards to implement Unique Device Identification (UDI) requirements as promulgated by the FDA in September 2013.

“The purpose of this document is to provide a foundation for the appropriate use of GS1 identification and barcode standards on medical devices within the context of the UDI Rule. This guideline does not provide any guidance or advice regarding regulatory compliance,” according to the guidance.

The document's release follows FDA's final rule, which requires medical device manufacturers to label their products with a UDI. The UDI system--comprised of the UDI code, application of the UDI to device labeling and packaging and a related database--will provide a standardized way to identify devices across all information sources and systems, including EHRs and devices registries.

Compliance deadlines roll out as follows: Sept. 24, 2014 for Class III devices; Sept. 25, 2015 for Class II implants and life supporting and sustaining devices; the rest of Class II devices by Sept. 25, 2016; and Class I devices by Sept. 25, 2018.

Access the guide here.