FDA Issues Final Guidance on UDI Compliance Requirements and Extends Enforcement Deadline
On July 22, the FDA posted its final guidance regarding Global Unique Device Identification Database (GUDID) submission requirements for certain Class I devices considered consumer health products. The guidance document, “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,” was updated to clarify that 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, 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. This new date provides a 75-day extension of the previously published guidance document.
The UDI requirements will then enter into force four years later than originally planned.
The postponement decision is partially justified by the fact that in this period, the COVID-19 emergency situation could make difficult the preparation of the UDI requirements, to the extent that medical devices manufacturers should be given more time. “We recognize, however, that the new policy regarding consumer health products, described in section III.B of this guidance, is being finalized close to that date and that some labelers may have been waiting for the publication of this guidance before planning for GUDID submission,” FDA said. “In light of these considerations, at this time, we do not intend to enforce the GUDID submission requirements … before December 8, 2022. We believe this brief extension of the policy may help facilitate submission of high-quality UDI data to GUDID and is consistent with the public health.” 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 following UDI requirements. Under 21 CFR 801.30(a)(2), Class I CGMP-exempt devices are excepted from UDI requirements.
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) |
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