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In 2013, the FDA issued a final rule to establish a system to adequately identify medical devices through distribution and use. This ruling requires the label of all Class II medical devices to include a Unique Device Identifier (UDI) for products to begin shipping on September 24, 2016.
FUJIFILM Medical Systems U.S.A., Inc. has reviewed its product portfolio and is adapting its business processes and systems to meet the UDI implementation requirements. We are adopting the use of GS1 standards to address product identification and barcoding within our systems, and we are committed to meeting all the requirements within the mandated time frame.
If you have any other questions, please contact us.
|Food and Drug Administration|