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  1. Unique Device Identification System (UDI System)

UDI Compliance Policies and UDI Rule Compliance Dates

October 19, 2022 Update: The FDA is reminding device industry and unique device identification (UDI) program stakeholders that the enforcement policy regarding the use of National Health Related Item Code (NHRIC) and National Drug Code (NDC) Numbers is only applicable to devices labeled prior to September 24, 2023. Devices labeled on or after September 24, 2023, must comply with all applicable UDI requirements, including the prohibition on the use of certain legacy FDA identification numbers (National Drug Code (NDC) and National Health Related Item Code (NHRIC) numbers) on the label. UDI Stakeholders: to help you understand what the end of this policy means for you, please read Legacy FDA Identification Numbers (NDC/NHRIC): Frequently Asked Questions.

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UDI Compliance Policies

The FDA established compliance dates in conjunction with the Unique Device Identification System final rule (UDI rule). Since publication of the UDI rule in 2013, and based on stakeholder feedback, the FDA has issued compliance policies for specific UDI requirements. The tables below represent the current UDI compliance policies.

Note: Compliance policies for all non-sterile Class III, Class II, and implantable, life-supporting or life-sustaining (I/LS/LS) devices are no longer in effect; these devices should bear a unique device identifier (UDI) unless an FDA-granted alternative or exception applies. For sterile Class III, Class II, and I/LS/LS devices, consult the FDA webpage on FDA-granted alternatives. More information on alternatives and exceptions, including FDA-granted alternatives and exceptions, can be found on UDI Exceptions and Alternatives.

UDI Policy Regarding Class I and Unclassified Devices, Direct Marking, and GUDID Requirements for Certain Devices

On July 22, 2022, the FDA posted the final guidance: Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices. This final guidance describes the FDA's compliance policy regarding Global Unique Device Identification Database (GUDID) submission requirements for certain Class I devices considered consumer health products. The update to this guidance reflects the finalization of the draft guidance "Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices", which was issued October 14, 2021, and following the consideration of public comments. This final guidance describes the FDA's compliance policy regarding GUDID submission requirements for certain Class I devices considered consumer health products. Additionally, the FDA does not intend to enforce the GUDID submission requirements for Class I and unclassified devices, other than implantable, life-supporting or life-sustaining devices, regardless of whether they are consumer health products, before December 8, 2022. I/LS/LS devices, including Class I I/LS/LS devices, are already expected to comply with GUDID submission requirements. This new date provides a 75-day extension of an existing FDA compliance policy published in the July 2020 version of this guidance.

This guidance also describes the FDA's direct mark compliance policy. The FDA does not intend to enforce the direct mark requirements under 21 CFR 801.45 for finished Class III, LS/LS, and Class II non-sterile devices, requiring a direct mark, that are manufactured and labeled prior to their applicable direct mark compliance date, and that remain in inventory, as well as for finished Class I and unclassified devices that are non-sterile, that are manufactured and labeled prior to September 24, 2022, and that remain in inventory, provided the device bears a non-UDI direct mark and the labeler has developed a method by which, using the non-UDI mark, the UDI may be made available. For certain sterile devices, the FDA has issued a UDI alternative under 21 CFR 801.55, which can be found UDI Exceptions and Alternatives.

The compliance policy described in the guidance does not apply to I/LS/LS devices, including Class I or unclassified I/LS/LS devices; labelers of these devices must already be in compliance with UDI requirements. Under 21 CFR 801.30(a)(2), Class I CGMP-exempt devices are excepted from UDI requirements.

Table 1. The table below summarizes the compliance policies set forth in this guidance by device type

Device Type UDI Rule Requirement Compliance Policy
Class I and unclassified devices, other than I/LS/LS devices, that are required to bear a UDI UDI labeling (21 CFR 801.20 & 801.50) The FDA does not intend to enforce prior to September 24, 2022 (see section III.A)
Class I and unclassified devices, other than I/LS/LS devices Standard date format (21 CFR 801.18) The FDA does not intend to enforce prior to September 24, 2022 (see section III.A)
Class I and unclassified devices, other than I/LS/LS devices, that are required to bear a UDI GUDID submission (21 CFR 830.300) The FDA does not intend to enforce prior to December 8, 2022* (see section III.B.2 for Class I devices and III.C for unclassified devices)
Consumer health products GUDID submission (21 CFR 830.300) See section III.B.1**
Class I and unclassified devices, other than LS/LS devices, that are required to bear a UDI and be directly marked with a UDI Direct mark (21 CFR 801.45)*** The FDA does not intend to enforce prior to September 24, 2022 (see section IV.B)
Non-sterile Class I devices and unclassified devices, including Class I and unclassified device constituents of a co-packaged combination product or kit other than LS/LS devices that are manufactured and labeled prior to September 24, 2022 Direct mark (21 CFR 801.45) The FDA does not intend to enforce UDI direct mark requirements when the device's UDI can be derived from other information directly marked on the device (see section IV.B)
Non-sterile Class II devices, other than LS/LS devices that are manufactured and labeled prior to September 24, 2018 Direct mark (21 CFR 801.45) The FDA does not intend to enforce UDI direct mark requirements when the device's UDI can be derived from other information directly marked on the device (see section IV.A)
Non-sterile LS/LS devices that are manufactured and labeled prior to September 24, 2015 Direct mark (21 CFR 801.45) The FDA does not intend to enforce UDI direct mark requirements when the device's UDI can be derived from other information directly marked on the device (see section IV.A)
Non-sterile Class III devices that are manufactured and labeled prior to September 24, 2016 Direct mark (21 CFR 801.45) The FDA does not intend to enforce UDI direct mark requirements when the device's UDI can be derived from other information directly marked on the device (see section IV.A)

* Denotes changes from the previous version of the guidance (issued in July 2020).

** For purposes of the 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.

*** Implantable devices are not required to be directly marked with a UDI. See Guidance for Industry and FDA Staff: Unique Device Identifier System: Frequently Asked Questions, Vol. 1.

UDI Rule Compliance Dates and Requirements by Device Type

The tables below represent the UDI requirements and compliance dates established by the FDA in the 2013 UDI Rule. Since publication of the UDI Rule and based on stakeholder feedback, the FDA has issued compliance policies for specific requirements.

 

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