Zdrowie i gospodarka · 30/08/2016

Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices; Guidance for Industry and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled "Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices." This guidance describes the Agency's intent not to enforce 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 finished devices that are manufactured and labeled prior to September 24, 2021. In addition, this guidance describes the Agency's intent to continue considering requests for continued use of FDA labeler codes under a system for the issuance of unique device identifiers (UDIs) that are submitted before September 24, 2021.