On August 30, 2016, the US Food and Drug Administration (FDA) published final guidance in which the agency announced it does not intend to enforce its prohibition against the inclusion of National Health Related Item Code (NHRIC) or National Drug Code (NDC) numbers on device labels and device packages for finished devices manufactured and labeled before September 24, 2021. In the final guidance—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 (Final Guidance)—the agency also indicates that it does not intend to take action against a labeler for incorporating a previously assigned FDA labeler code into its unique device identifier (UDI) without requesting approval to do so if the labeler submits a request by September 24, 2021.
The UDI final rule requires that the label and every device package of a medical device distributed in the US bear a UDI unless an exception or alternative applies. The UDI system is being phased in over seven years. Prior to the establishment of the UDI system, however, some companies placed NHRIC or NDC numbers on the labels and packages of certain medical devices to facilitate reimbursement, supply chain and procurement processes. To further the uptake of a standardized UDI system, the UDI final rule rescinds any NHRIC or NDC number assigned to a medical device and prohibits the use of such numbers on a device label or package effective as of the date a device is required to include a UDI on its label.
In the draft guidance, FDA announced that it did not intend to enforce before September 24, 2021 the prohibition against including NHRIC and NDC numbers on device labels and packages—but only insofar as such devices were manufactured and labeled before September 24, 2018. In comments submitted to the public docket, commenters expressed concern that retailers and pharmacies would not be able to complete the work to transition away from NHRIC and NDC numbers by September 24, 2018, and that for certain products with extended shelf lives, retailers and pharmacies would be required to return products manufactured and labeled before September 24, 2018 back to the device labeler if such products remain unsold in September 2021. In recognition of these concerns, the agency revised the Final Guidance to reflect the agency’s intent not to enforce the prohibition with respect to finished devices that are manufactured and labeled prior to September 24, 2021.
In the draft guidance, FDA also stated its intent to not take enforcement action against a labeler for incorporating a previously assigned FDA labeler code into its UDI without requesting approval to do so if the labeler submits a request that meets regulatory requirements by September 24, 2018. In the Final Guidance, FDA extended this policy to give labelers such flexibility insofar as requests are submitted before September 24, 2021.