FDA loosens UDI requirements for lowest risk devices, extends deadline for others
The US Food and Drug Administration is relaxing its unique device identified (UDI) rule requirements for low-risk class I consumer health products. Other class I and unclassified devices will still need to follow UDI requirements, though FDA announced it will extend its compliance deadline for those devices to 8 December 2022.On 22 July FDA released a final guidance titled, 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 that supersedes the agency’s 2020 UDI compliance policy guidance. The agency says after further reflection of how its UDI rule may impact manufacturers and consumers, it is extending the enforcement discretion period for low-risk class I and unclassified devices. (RELATED: Guidance: FDA holds off on enforcing certain UDI requirements, Regulatory Focus 30 June 2020)
FDA had previously required certain over-the-counter class I devices that the agency calls consumer health products to implement the UDI rule. That meant capturing the product’s universal product code (UPC) and uploading it to FDA’s Global Unique Device Identification Database (GUDID). The agency now says that it realizes that the UPC code may be temporary and change frequently for the same product.
“With respect to class I devices that are consumer health products, FDA believes that the entry of UDI data into GUDID, especially given the frequent changes to the UPCs serving as the UDIs for these devices, is burdensome to stakeholders,” the guidance states. “Further, FDA considered the public health benefit of GUDID submission for consumer health products and the risks to public health if GUDID submission is not provided for these devices. After reviewing available postmarket information, such as medical device reports and recall data for class I devices, FDA has a better understanding of the devices and device characteristics for which GUDID information is particularly useful in evaluating and improving device safety throughout a product lifecycle, as well as those for which GUDID information may be less important in this regard.”
With that in mind, FDA says it does not intend to enforce GUIDID submission requirements for consumer health products, though other class I products do still need to fulfill the requirements.
In the guidance, FDA also says that other class I and unclassified devices, other than implantable, life-supporting, or life-sustaining (I/LS/LS) devices that are supposed to meet GUDID submission requirements under its 2020 UDI Compliance Policy Guidance by 24 September 2022 will be given an additional 75 days, or until 8 December 2022, to comply with the policy.
“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.”
Other policies laid out in the guidance however need to continue to follow the timelines set in the 2020 UDI Compliance Policy guidance and FDA’s UDI webpage has additional information on UDI compliance dates.
Guidance, Federal Register Notice
