FDA provides guidance on compliance dates for Class I and unclassified devices and devices requiring direct marking

July 2, 2020

The Food and Drug Administration (FDA) 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.”

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This guidance revises the guidance by the same title issued November 5, 2018, and describes the FDA's intention with respect to the enforcement of unique device identification (UDI) requirements for class I and unclassified devices, other than implantable, life-sustaining, or life-supporting (I/LS/LS) devices. In this revised guidance, FDA clarifies that, at this time, in light of the considerations described in the guidance, it does not intend to enforce standard date formatting, labeling, and Global Unique Device Identification Database (GUDID) data submission requirements for these devices before September 24, 2022. The guidance is immediately in effect, but it remains subject to comment in accordance with the Agency's good guidance practices. 

The UDI Rule requires a device to bear a UDI on its label and packages unless an exception or alternative applies (see 21 CFR 801.20), and special labeling requirements apply to stand-alone software regulated as a device (21 CFR 801.50). The UDI Rule also requires that data pertaining to the key characteristics of each device required to bear a UDI be submitted to FDA's GUDID (21 CFR 830.300). In addition, the UDI Rule added 21 CFR 801.18, which requires certain dates on device labels to be in a standard format. For devices that: (1) Must bear UDIs on their labels and (2) are intended to be used more than once and reprocessed between uses, 21 CFR 801.45 requires the devices to be directly marked with a UDI. Compliance dates for these labeling, GUDID data submission, standard date format, and direct marking requirements can be found in the preamble to the UDI Rule, 78 FR 58786 at 58815 to 58816. 

This guidance describes FDA's intention with regard to enforcement of these requirements for class I and unclassified devices, other than I/LS/LS devices. This revised guidance supersedes the November 2018 guidance of the same title, “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.” In this revised guidance, FDA states that, at this time, in light of the considerations described in the guidance, it does not intend to enforce the requirements under 21 CFR 801.18, 801.20, 801.50, and 830.300 for class I and unclassified devices, other than I/LS/LS devices, prior to September 24, 2022, regardless of the date they are manufactured and labeled. The guidance explains that FDA believes it is important to continue focusing its resources on addressing UDI implementation issues and data quality for higher risk devices and, at this time, concludes that continuing its existing policy with regard to enforcement of these requirements for class I and unclassified devices, other than I/LS/LS devices, is consistent with the public health. In addition, while some editorial changes were made to improve clarity, other policies described in the November 2018 guidance remain the same in the revised guidance. 

FDA has the guidance

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