This page provides information about the use of National Drug Code (NDC) and National Health Related Item Code (NHRIC) created using labeler codes previously assigned to device manufacturers by the FDA (referred to here as “legacy FDA identification numbers”) on device labels and the enforcement policy related to these legacy identifiers, as set forth in the FDA’s May 2021 guidance, Enforcement Policy Regarding Use of National Health Related Item Code and National Drug Code Numbers on Device Labels and Packages.
· For finished devices manufactured and labeled prior to September 24, 2023, the guidance states that the FDA does not intend to object to the use of legacy FDA identification numbers on device labels and device packages.
· For devices manufactured and labeled on or after September 24, 2023, this policy does not apply.
This page includes responses to common questions about the guidance to help device labelers preparing to transition into compliance. The FDA expects device manufacturers and/or labelers to be aware of UDI and other FDA regulatory requirements.
