Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices; Guidance for Industry and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices." This guidance updates the previous version of the guidance, "Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking," issued July 1, 2020. This final guidance explains FDA's compliance policy regarding Global Unique Device Identification Database (GUDID) submission requirements for certain class I devices considered consumer health products and describes how a labeler of a class I devices can determine if its device is one of these devices. Additionally, the guidance explains that FDA intends to extend our existing compliance policy regarding GUDID submission requirements for class I and unclassified devices, other than implantable, life-supporting, or life- sustaining (I/LS/LS) devices, for an additional 75 calendar days.