Class I and Unclassified Device UDIs: FDA Pushes Back Enforcement Dates by 2 Years
Posted 02 November 2018 | By
The US Food and Drug Administration (FDA) released new guidance Friday that effectively pushes back by two years the date by which FDA will enforce certain unique device identifier (UDI) requirements for class I and unclassified devices.
The new dates by which FDA said it will enforce for class I and unclassified devices, other than implantable, life-supporting, or life-sustaining (I/LS/LS) devices are: 24 September 2020, 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 24 September 2022 for direct mark requirements (21 CFR 801.45).
Finished class I and unclassified devices, other than I/LS/LS devices, manufactured and labeled prior to 24 September 2018, “are excepted from UDI labeling and GUDID data submission requirements for a period of three years after the established compliance date or until September 24, 2021,” the guidance adds.
“The Agency intends to focus its resources on addressing existing implementation challenges and optimizing the quality and utility of UDI data for higher-risk devices before focusing on UDI implementation issues for lower-risk devices,” the guidance explains. “Undertaking this endeavor now will help ensure the transition from development of the unique device identification system to widespread use and sustainability.”
This guidance also describes FDA’s direct mark compliance policy for class III, LS/LS, and class II devices that are non-sterile, 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 non-sterile, that are manufactured and labeled prior to 24 September 2022 and that remain in inventory.
“FDA does not intend to enforce the direct mark requirements under 21 CFR 801.45 for these devices when the device’s unique device identifier (UDI) can be derived from other information directly marked on the device,” the guidance says.
This guidance supersedes, “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Immediately In Effect Guidance for Industry and Food and Drug Administration Staff, issued January 16, 2018.”
Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking