Zdrowie i gospodarka · 03/02/2016

Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability and Request for Comments

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance for industry and FDA staff entitled "Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices." When finalized, this draft document will describe the Agency's intent not to enforce, before September 24, 2021, 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 September 24, 2018. In addition, when finalized, this draft guidance will describe the Agency's intent to continue considering requests for continued use of FDA labeler codes under a system for the issuance of unique device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) until September 24, 2018. This draft guidance is not the final version of the guidance nor is it in effect at this time.