The FDA Issues Guidance on the Enforcement Policy Regarding Use of NHRIC and NDC Numbers on Device Labels and Packages
Today, the U.S. Food and Drug Administration (FDA) issued the guidance Enforcement Policy Regarding Use of National Health Related Item Code (NHRIC) and National Drug Code (NDC) Numbers on Device Labels and Packages. The guidance explains that the FDA does not intend to object to the use of legacy NHRIC and NDC numbers on device labels and device packages for finished devices that are manufactured and labeled prior to September 24, 2023.
The FDA had a previous enforcement policy guidance on this same topic, 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 (issued August 30, 2016), which stated that the FDA did not intend to enforce the regulatory requirements to remove legacy FDA identification numbers from device labels and packages for devices manufactured and labeled before September 24, 2021.
Questions?
If you have questions about this guidance, contact the FDA UDI Help Desk.
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