Overview
In Depth
On June 2, 2017, the US Food and Drug Administration (FDA) announced that it plans to delay the dates by which certain Class I devices and unclassified devices must comply with the agency’s unique device identification (UDI) system requirements. Previously, FDA was scheduled to begin enforcement of the UDI system requirements for regulatory labeling, Global Unique Device Identification Database (GUDID) data submission and date formatting on September 24, 2018, and direct mark requirements on September 24, 2020, for Class I devices and unclassified devices that are not implantable, life-supporting or life-sustaining. In the announcement, FDA indicated that it intends to issue a guidance document that will provide enforcement discretion for two additional years beyond the current deadlines (i.e., until September 24, 2020, and September 24, 2022, respectively). The agency intends to exercise enforcement discretion with respect to these devices so that agency can focus on issues related to the integration of the UDI for higher-risk devices into electronic health records throughout the health care system.
This is not the first time that FDA has issued a letter to device labelers extending the UDI enforcement dates for certain devices, which were initially established in a 2013 final rule. The final rule set different effective dates for different classes of devices, with higher risk devices (e.g., Class III devices) required to come into compliance first. In the June 2 letter, FDA is not changing the deadline for labelers of the higher-risk devices that currently must comply with the final rule.
Low-risk and unclassified device labelers are likely to welcome the extension, particularly insofar as they supported industry’s efforts to obtain an extension from FDA, and should monitor communications from the agency to confirm the release of the guidance referenced in the letter. In the interim, device labelers should continue to submit inquiries regarding alternatives to or requests for exemptions from UDI requirements, if applicable.
