FDA Works on Draft ID System for Medical Devices, Supplies

Nov. 5, 2007—The U.S. Food and Drug Administration (FDA) may soon require manufacturers of medical devices and supplies to apply unique device identification (UDI) mechanisms to individual items so they can be automatically tracked and traced in the supply chain. The agency is also urging companies to file reports electronically whenever an item is involved in an adverse event. Currently, such reports are filed in paper format and must then be manually entered into a computerized system.

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