December 05, 2013 Articles

Medical Device Tracking: The FDA's New Unique Device Identification System

By Kara T. Stubbs and Wynn J. Maxwell

On September 24, 2013, the Food and Drug Administration (FDA) published its final rule regarding a tracking system for the vast majority of medical devices. After almost a decade and a half of wrangling, the FDA's unique device identification system project has finally come to fruition. Designed to reduce medical error, enhance analysis of medical devices, and allow for easier identification of problem devices, the unique device identification system has been hailed as a major step forward in the areas of patient safety, modernization of post-market surveillance, and the facilitation of medical technological innovation.

The Unique Device Identification System
The unique device identification system is made up of two major components. First, each qualifying product is required to have a unique device identifier (UDI), a numeric or alphanumeric code that distinguishes each individual product. The UDI contains a unique tracking number known as a device identifier (DI), similar to a stock keeping unit (SKU). The UDI may also contain a product identifier (PI), a variable code that reflects information normally on the device's label. The information conveyed by a PI may include the product's batch/lot number, any expiration dates, the manufacturing date, the serial number, and the section 1271.290(c) code required for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device.

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