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Medical Devices / Regulatory Affairs

FDA Holds Off on UDI Label Enforcement for Devices Made Before September 2021

Sept. 12, 2016

The FDA announced it does not intend to enforce the requirement to use its unique device identifier system for labels on medical devices manufactured and labeled before Sept. 24, 2021.

In final guidance issued Aug. 30, the agency said stakeholders had expressed concern that pharmacies and other entities in the supply chain were not prepared for the transition. The deadline for labeling most Class I and Class II devices is Sept. 24.

The UDI codes are replacing the National Health Related Item Code and National Drug Code numbers used on device labels and device packages. On the date a device or device package is required to bear a UDI code on its label, the NHRIC and NDC numbers would not be allowed.

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