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.
Fda unique device identification medical devices.
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.
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.
A dedicated global identification protocol is needed to unambiguously identify medical devices in the healthcare supply chain.