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Focus on Regulation

Tag Archives: GUDID

FDA Pushes UDI System Compliance Date Back for Class I and Unclassified Devices

On June 2, 2017, the U.S. Food and Drug Administration (FDA) announced in a letter to device labelers that it will issue a guidance document stating that FDA will exercise its enforcement discretion for the unique device identifier (UDI) compliance date for certain class I devices which are subject to current Good Manufacturing Practice (cGMP) requirements and unclassified devices.