The FDA said today that it will grant manufacturers of Class 1 and unclassified medical devices and certain others more time to add unique device identifiers (UDIs) to their products.
These companies will now have until Sept. 24, 2022 to comply with the agency’s UDI rule, including standard date formatting, labeling and Global Unique Device Identification Database (GUDID) data submission requirements. The new guidance, published here, revises guidance issued in 2018. It also covers certain devices that require direct marking, but does not include implantable, life-sustaining, or life-supporting devices.
The FDA implemented a final rule in 2013 requiring UDIs on most medical devices, including updated labeling designs and requiring that certain information be submitted to GUDID. The national UDI system is intended to provide structure to improve best practices, including in care and delivery of medical devices and is especially important for high-risk implantable devices.
The latest guidance, titled “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,” is immediately in effect, but the public may submit comments on it here.