The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance entitled “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking; Immediately in Effect Guidance for Industry and Food and Drug Administration Staff.”
This guidance describes FDA’s intention with respect to the enforcement of unique device identification requirements for class I and unclassified devices, other than implantable, life-sustaining, or life-supporting (I/LS/LS) devices.
FDA does not intend to enforce standard date formatting, labeling, and Global Unique Device Identification Database (GUDID) data submission requirements for these devices before Sept. 24, 2020. In addition, FDA does not intend to enforce direct mark requirements for these devices before Sept. 24, 2022.
This guidance also describes FDA’s direct mark compliance policy for class III, LS/LS, and class II devices that are nonsterile, manufactured and labeled prior to their applicable direct mark compliance date, and remain in inventory, as well as for class I and unclassified devices that are nonsterile, manufactured and labeled prior to Sept. 24, 2022, and remain in inventory. FDA does not intend to enforce the direct mark requirements for these devices when the device’s unique device identifier (UDI) can be derived from other information directly marked on the device.
The guidance document is immediately in effect, but it remains subject to comment in accordance with the Agency’s good guidance practices.
