FDA issues draft guidance on UDIs

Editor's Note

The Food and Drug Administration (FDA) on February 3 released a draft guidance document, “Enforcement policy on national health related item code and national drug code numbers assigned to devices.”

The draft describes the FDA’s intent not to enforce before September 24, 2021, the prohibition against National Health Related Item Code (NHRIC) or National Drug Code (NDC) numbers on device labels and packages.

The draft also describes the FDA’s intent to continue considering requests for continued use of NHRIC and NDC codes under a system for the issuance of unique device identifiers (UDIs) until September 24, 2018.

Medical devices are currently labeled with NHRIC and NDC codes. These codes will no longer be allowed on a device once the devise has been issued a UDI.

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