Guidance: FDA holds off on enforcing certain UDI requirements

Regulatory NewsRegulatory News | 30 June 2020 |  By 

The US Food and Drug Administration (FDA) has issued a final guidance for unique device identification compliance dates for Class I and unclassified medical devices. The immediately effective guidance also clarifies agency policy regarding compliance dates for certain devices requiring direct marking.
In the guidance, FDA clarifies that it does not currently intend to enforce standard date formatting, unique device identification (UDI) labeling, or Global Unique Device Identification Database (GUDID) data submission requirements for class I and unclassified devices until 24 September 2022.  The intent not to enforce does not apply to implantable, life-supporting or life-sustaining devices.
The agency cited the complexity of implementation and integration of the UDI system, together with the paramount importance of marshaling resources to address the public health emergency of the COVID-19 pandemic, as considerations in its intent not to enforce the original compliance dates.
Following the 24 September 2013 publication of the FDA’s final UDI Rule, “the Agency had identified complex policy and technical issues that required resolution to help ensure that UDI data are high quality and are available in standardized ways,” according to background laid out in the guidance.
“Fully realizing the benefits of the unique device identification system depends on UDI being integrated into data sources throughout our healthcare system, including in the supply chain, electronic health records, and registries. This requires UDI data to be of a high quality, such that all stakeholders in the healthcare community have sufficient confidence in the accuracy and completeness of that data,” observed FDA.
FDA acknowledged that “preparing to implement UDI requirements while addressing the challenges related to Coronavirus Disease 2019 (COVID-19) could be very difficult and could divert resources from COVID-19 response efforts.” Adds the guidance, “To the extent this policy helps labelers remain focused on public health needs related to COVID-19, we believe the policy is further consistent with the public health.”
Under the original phase-in of FDA’s UDI system, 24 September 2020 was the compliance date for direct mark requirements under 21 CFR 801.45. 24 September 2018 was the compliance date for standard date formatting (21 CFR 801.18) and labeling (21 CFR 801.20 and 801.50), as well as the data submission compliance date for the GUDID (1 CFR 830.300).
The guidance lays out which finished devices were excepted from the requirement to bear a UDI based on dates of manufacture and labeling, and which are excepted from GUDID data submission requirements.
Direct mark UDI requirements for Class II, III, and life-supporting-/sustaining devices will not be enforced by FDA if the device’s UDI “can be derived from other information directly marked on the device,” according to the guidance. FDA is planning to develop a new field or fields in GUDID to capture such information. FDA declared a similar intent not to enforce UDI direct mark requirements for Class I and unclassified devices, with GUDID fields in the works for these devices as well.


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Tags: devices, FDA, medical, US

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