FDA Proposes New UDI Barcode Requirement for Medical Devices

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FDA Proposes New UDI Barcode Requirement for Medical Devices

by Nate Schubert

Although Congress passed the Food and Drug Administration Amendments Act in 2007 in part to establish a unique device identification system for medical devices through distribution and use, The FDA only recently acted on the matter by recognizing the GS1 GTIN as the correct barcode type to be used in the system. Published on July 3, 2012, the proposed FDA Unique Device Identification System rule would require medical devices and their packaging to include a unique device identifier, or UDI, represented both as a barcode and as well in plain-text.

The UDI system would be a database managed much the same as the GS1 UPC system that has been used for many years, allowing the effective communication of product information and pricing that is intended for sale in retail locations throughout the world. Medical devices and equipment may not be directly identified via this unique code, but instead recognized through a central database that associates the unique ID with the product and any other information that may be required by the FDA. This new system is expected to benefit the quicker identification of problems with medical devices and make the product recall process more effective, both of which will improve the safety of patients everywhere.

The UDI system has not been made into a requirement as of yet, and there are still a lot of finer-points that need to be decided before the FDA’s proposal becomes a requirement. The system may utilize GS1 GTIN barcode types as referenced in IDAutomation’s GTIN barcode compliance chart. This requirement would impact manufacturers, reprocessors, specification developers, repackagers, relabelers and any other entity that  is responsible for applying such label to qualifying medical devices.