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Verify Brand Supports the Proposed FDA Unique Device Identification (UDI) System for Medical Devices
Date:7/26/2012

MINNEAPOLIS, July 26, 2012 /PRNewswire/ -- On July 10, 2012, the Food and Drug Administration released its proposed rule for Unique Device Identification (UDI) of medical devices in the United States. The system focuses on creating standardized device identifiers that are applied to packaging and devices, corresponding to entries in an FDA-managed Global Unique Device Identification Database (GUDID). The rule contains guidelines for UDIs being applied to devices in both human-readable form and encoded in some type of Auto ID technology (e.g., barcode, RFID). Within the GUDID, additional device details will be stored, such as manufacturer details, device name, description and characteristics. The proposed system is expected to provide numerous benefits including: reduction in medical errors, simplified integration of device identification with data systems, and facilitation of faster response to adverse events and recalls.

The proposed UDI rule is significantly important because it lays the foundation for standardized medical device serialization and tracking in the U.S. As stated in the proposed rule, potential additional benefits of UDI are increased detection of counterfeit devices and improvement in supply chain visibility. Through deep experience with serialization and traceability, Verify Brand can help medical device manufacturers understand the end-to-end impacts of UDI and serialization - from packaging/labeling and distribution to meeting regulatory requirements and enhancing product authentication.

Verify Brand's VB Enterprise software supports all stated standards in the proposed UDI rule, including:

  • GS1 GTIN and HIBCC HIBC for device identification
  • HL7 SPL data transmission to the GUDID via the VB Enterprise Message Management Service
  • Production Identifier elements: lot/batch, serial number, expiration date, manufacture date

Verify Brand is a recognized leader i
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SOURCE Verify Brand, LLC
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