HIDA Government Affairs Alert

FDA Announces UDI Enforcement Discretion Due To COVID-19

July 10, 2020

As issues with sourcing, fraudulent, or noncompliant supplies have been exacerbated due to COVID-19, the Food and Drug Administration (FDA) has announced it does not intend to enforce standard date formatting, Unique Device Identification (UDI) labeling, and Global Unique Device Identification Database (GUDID) data submissions for class I and unclassified devices, other than I/LS/LS devices, before September 24, 2022 regardless of the date they are manufactured and labeled.

Furthermore, the FDA does not intend to enforce UDI direct mark requirements for finished class I and unclassified devices, including class I and unclassified device constituents of a copackaged combination product or kit, that are not LS/LS, that are non-sterile, that were manufactured and labeled prior to September 24, 2022, and that remain in inventory, when the device’s UDI can be derived from other information directly marked on the device.

The guidance establishing the enforcement discretion is being implemented without prior public comment because the FDA has determined that prior public participation is not feasible or appropriate given the global pandemic. Furthermore, FDA has determined that the guidance document presents a less burdensome policy that is consistent with public health. As such, the guidance is being implemented immediately, but it remains subject to comment in accordance with the Agency's good guidance practices.

The announcement has not altered other policies that were conveyed in a previous (November 2018) version of the guidance.

Read Final Guidance Document (PDF)►

HIDA will continue to stay engaged and follow for any additional developments. Please feel free to reach out to us by email at HIDAGovAffairs@HIDA.org or 703-549-4432.