USA – Class I and Unclassified Device UDIs: FDA Pushes Back Enforcement Dates by 2 Years

he US Food and Drug Administration (FDA) released new guidance Friday that effectively pushes back by two years the date by which FDA will enforce certain unique device identifier (UDI) requirements for class I and unclassified devices.

The new dates by which FDA said it will enforce for class I and unclassified devices, other than implantable, life-supporting, or life-sustaining (I/LS/LS) devices are: 24 September 2020, for the following requirements: Standard date formatting (21 CFR 801.18), Labeling (21 CFR 801.20, 21 CFR 801.50) and Global Unique Device Identification Database (GUDID) data submission (21 CFR 830.300); and 24 September 2022 for direct mark requirements (21 CFR 801.45).

Finished class I and unclassified devices, other than I/LS/LS devices, manufactured and labeled prior to 24 September 2018, “are excepted from UDI labeling and GUDID data submission requirements for a period of three years after the established compliance date or until September 24, 2021,” the guidance adds…