Fda Unique Device Identification Medical Devices
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The fda established the unique device identification system to adequately identify medical devices sold in the united states from manufacturing through distribution to patient use.
Fda unique device identification medical devices. The global unique device identification database gudid is a database administered by the fda that will serve as a reference catalog for every device with a unique device identifier udi. The united states food and drug administration fda implemented a unique device identification udi system to assign a unique identifier to all medical devices distributed in the us. This document will assist industry particularly labelers as defined under 21 cfr 801 3 and fda staff in understanding fda s requirements for direct marking of devices for unique device.
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