FDA Delays New UDI Requirements Until September 2022

The FDA has decided to push back enforcement of new unique device identification (UDI) requirements for class I and unclassified medical devices until Sept. 24, 2022, due to complications caused by the pandemic.

The delay is the third time that the agency has postponed enforcement of certain requirements under its 2013 UDI final rule.

The agency noted in new guidance that COVID-19 and other factors are creating obstacles for labelers in meeting the UDI direct mark requirements for certain finished devices already manufactured, labeled and in inventory.