FDA Pushes Back Direct Label UDI Requirements


Posted November 6, 2018

The Food and Drug Administration (FDA) is giving medical device manufacturers additional breathing room to adopt unique device identification (UDI), specifically as it relates to direct mark requirements, in which a UDI is placed directly on a reusable device that is reprocessed between uses.

As described in the immediately-in-effect guidance document, Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Markingthe FDA will delay enforcement of direct mark compliance dates for Class I and unclassified devices (other than life-supporting or life-sustaining devices) until Sept. 24, 2022. After that date, the FDA wrote that it will not enforce UDI direct mark requirements if those devices are non-sterile, were manufactured and labeled prior to Sept. 24, 2022, and remain in inventory if the device’s UDI can be derived from other information that’s directly marked on the device.

In addition, the FDA has added a one-year grace period for medical devices that require a direct mark, are not implantable or life-supporting or life-sustaining, and were manufactured and labeled prior to their label compliance date. However, devices manufactured after their label compliance date but before their direct mark compliance date must still meet their previous deadlines.

“This policy allows some realization of the benefits of UDI to patient safety for inventory devices that do not bear a UDI. The lower burden of the approach outlined in this guidance also reduces the risk that industry will choose to avoid the cost of remediation by discarding inventory, potentially creating device shortages and negatively impacting patients and providers,” the FDA wrote. “Weighing the benefits and risks, we conclude that this compliance policy for certain inventory devices appropriately serves the public health.”

The FDA’s UDI rule was developed to better track medical devices throughout their life cycle through the use of identification numbers (usually on the device’s label) and that are tracked in an online database (GUDID). FDA’s published a final rule in 2013 that established the UDI system with an expected seven-year phase-in period based on a device’s classification. However, manufacturers reported that they were struggling to meet UDI requirements in 2016, prompting the FDA to provide additional guidance on how the required information should be ordered. In January, the FDA delayed enforcement of UDI compliance deadlines some lower-risk devices.

During implementation of UDI the FDA identified “complex policy and technical issues that require resolution,” the agency wrote in its most recent guidance document, and it is currently focused on addressing “existing implementation challenges and optimizing the quality and utility of UDI data for higher-risk devices before focusing on UDI-implementation issues for lower-risk devices.”

While the current FDA guidance goes into effect immediately, public comments can still be submitted online at www.regulations.gov.