The U.S. Food and Drug Administration (FDA) has issued an “immediately in effect” guidance which rolls back the compliance deadlines for its rules regarding labeling and data submission requirements applicable to unique device identification (UDI) systems in class I and unclassified medical devices.
Under FDA regulations, UDI requirements for class 1 and unclassified medical devices were due to be phased in starting in September 2018, beginning with requirements for standard date formatting, labeling, and data submissions to the Global Unique Device Identification Database (GUDID) of UDI systems. However, according to the guidance issued on January 12th, the FDA says it “does not intend to enforce…requirements…for these devices before September 24, 2020.”
The extension of the enforcement policies described in the guidance does not apply to class 1 and unclassified implantable, life-supporting or life-sustaining (I/LS/LS) devices, as these were required to comply with the UDI system requirements as of September 2015.
The complete text of the FDA’s guidance on UDI compliance is available at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM592340.pdf.