The FDA said today it will allow medtech manufacturers to continue using certain device older labeling codes for a limited time.
The new guidance extends until September 24, 2023, the deadline for removing out-of-date labeling codes that the agency issued before establishing its unique device identifier (UDI) system in 2013. Before UDI, the agency issued manufacturers National Health Related Item Code (NHRIC) and National Drug Code (NDC) numbers for their device labels.
Congress enacted the UDI law in 2007, intending to have the FDA use billing claims data with the UDI number to track medical device safety. Medtech companies began incorporating UDIs into their labeling in 2014.
“We believe that extending the policy for a limited additional time as stakeholders continue to make changes to transition medical device reimbursement, supply chain, and procurement systems and processes away from use of legacy NHRIC and NDC numbers is appropriate and in the interest of the public health,” the agency said in the new guidance. “By September 24, 2023, more devices will bear UDIs, and we anticipate reimbursement, supply chain, and procurement systems will be better prepared to rely on UDIs. We also intend to work to encourage UDI adoption throughout healthcare data systems, including in those that currently rely on NHRIC and NDC numbers to help facilitate a smooth transition away from use of these legacy identifiers on device labels and fully realize the benefits of UDI.”