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# FDA Guidance on Enforcement Discretion on Device Codes
- URL: https://www.fdaweb.com/fda-guidance-on-enforcement-discretion-on-device-codes/
- Published: 2016-08-29T12:00:00.000Z
- Updated: 2026-09-14T21:27:33.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5136643

FDA has released a [final guidance](http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM484092.pdf?ref=fdaweb.com) on “Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices.” The guidance describes the agency’s enforcement of a prohibition against providing National Health Related Item Code or National Drug Code numbers on device labels and device packages described in 21 CFR 801.57(a)-(b). It says FDA does not intend to enforce this prohibition with respect to finished devices that are manufactured and labeled prior to 9/24/2021\. In addition, it describes the agency’s intent to consider requests for continued use of FDA labeler codes under its unique device identifiers system.