USA – UDI : Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking

FDA’s unique device identification system is designed to adequately identify devices through distribution and use. Its requirements were designed to be phased in over seven years according to established compliance dates based primarily on device classification.

The compliance dates established for class I and unclassified devices, other than implantable, life-supporting, or life-sustaining (I/LS/LS) devices are:

  • September 24, 2018, 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
  • September 24, 2020, for direct mark requirements (21 CFR 801.45).

This guidance describes FDA’s intention with regard to enforcement of these requirements for class I and unclassified devices.

This guidance also describes FDA’s direct mark compliance policy for class III, LS/LS, and class II devices that are non-sterile, that are manufactured and labeled prior to their applicable direct mark compliance date, and that remain in inventory, as well as for class I and unclassified devices that are not LS/LS devices, that are non-sterile, that are manufactured and labeled prior to September 24, 2022, and that remain in inventory…