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Guidance on National Drug Code Numbers for Devices


Federal Register Notice: FDA makes available a draft guidance for industry and FDA staff entitled Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices. It will describe the agency’s intent not to enforce, before 9/24/21, the prohibition against providing National Health Related Item Code (NHRIC) or National Drug Code (NDC) numbers on device labels and device packages, with respect to certain finished devices manufactured and labeled prior to 9/24/18. Also, it will describe FDA’s intent to continue considering requests for continued use of FDA labeler codes under a system for the issuance of unique device identifiers (UDIs) until 9/24/18. To download this guidance, click here. To view this notice, click here.