Zdrowie i gospodarka · 03/02/2016

FDA Announces Draft Guidance on Enforcement Policy for National Health Related Item Code and National Drug Code Numbers Assigned to Devices

The Food and Drug Administration (FDA) has released a draft guidance outlining its intent not to enforce a prohibition on providing National Health Related Item Code (NHRIC) or National Drug Code (NDC) numbers on device labels and packages for certain finished devices manufactured before September 24, 2018, and its consideration of requests for continued use of FDA labeler codes under a unique device identifier (UDI) system until September 24, 2018.