FDA Class 1 Medical Devices : UDI Requirements
October 24 2022
FDA has updated this guidance to include FDA’s compliance policy regarding Global Unique Device Identification Database (GUDID) submission requirements for certain class I devices considered consumer health products. Specifically, FDA does not intend to enforce the GUDID submission requirements under 21 CFR 830.300 for class I devices considered to be consumer health products that are required to bear a UDI on their labels and device packages. Additionally, FDA does not intend to enforce the GUDID submission requirements under 21 CFR 830.300 for class I and unclassified devices, other than implantable, life-supporting, or life-sustaining (I/LS/LS) devices, regardless of whether they are consumer health products, before December 8, 2022 (an additional 75 calendar days).
On September 24, 2013, the FDA published a final rule establishing a UDI system designed to adequately identify devices through distribution and use (the “UDI Rule”). Phased
implementation of the regulatory requirements set forth in that final rule is based on a series of established compliance dates based primarily on device classification, which range from
September 24, 2014, to September 24, 2020.
The UDI Rule requires a device to bear a unique device identifier (UDI) on its label and
packages unless an exception or alternative applies (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). GUDID provides a repository of device safety information for FDA. Most of the information submitted to GUDID is also available to the public through AccessGUDID. AccessGUDID enables healthcare providers and patients to obtain useful safety information on specific device models, such as sterility requirements and MRI compatibility information.
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 Policy for GUDID Submission Requirements for Class I Devices
Class I Devices Considered Consumer Health Products
FDA does not intend to enforce the GUDID submission requirements under 21 CFR 830.300 for class I devices considered consumer health products that are required to bear a UDI on their labels and device packages. For purposes of this guidance, “consumer health products” means 510(k)-exempt class I devices that are sold directly to consumers over-the-counter in brick-and-mortar and/or online stores and that do not fall within one or more of the categories identified in section III.B.2. In addition to being sold directly to consumers, some consumer health products may be sold to or used in professional healthcare facilities. 20 Consumer health products are typically labeled with a UPC, which may serve as the UDI for class I devices (21 CFR 801.40(d)).
Class I Devices Not Considered Consumer Health Products by FDA
FDA has determined that class I devices that we do not consider consumer health products may pose greater risks to public health and, based on FDA’s analysis, GUDID data is particularly important to monitoring the safety of these devices. These potentially higher risk devices are typically used exclusively in professional healthcare facilities and are often subject to additional regulatory controls.
Class I devices that fall into one or more of the categories described below are not considered consumer health products for purposes of this guidance and, therefore, do not fall within the compliance policy described in section III.B.1 of this guidance. However, FDA does not intend to enforce the GUDID submission requirements under 21 CFR 830.300 for class I devices, other than I/LS/LS devices,22 regardless of whether they fall within that compliance policy, before December 8, 2022 (an additional 75 calendar days).
Class I Reserved Devices
Life-Supporting or Life-Sustaining Devices
Certain Devices Distributed to Professional Healthcare Facilities and Intended for Use by Healthcare Professionals Only
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