FDA pushes back UDI deadline for convenience kit and repackaged device labelers

By Stewart Eisenhart, Emergo Group

Medical device regulators at the US Food and Drug Administration have notified labelers of some Class II devices that their deadline for Unique Device Identification (UDI) compliance has been extended to September 2018.

The extension affects three broad categories of devices, all of which now have a compliance date ofSeptember 24, 2018 for UDI labeling as well as Global Unique Device Identification Database (GUDID) compliance.

• “Convenience kits,” or two or more devices (Class II or Class I and II in combination) packaged together without individual labels; the FDA has extended compliance deadlines for these devices in order to finalize draft guidance the agency issued in early 2016 addressing how to properly define such products
• Repackaged Class II single-use devices that are not labeled individually with a UDI
• Combination products whose medical device components are assigned to the FDA’s Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) for premarket review and oversight.

However, the UDI and GUDID deadline extensions do not apply to any devices falling into one of the aforementioned categories in cases where a device serves an implantable, life-sustaining or life-supporting purpose.

For more analysis of the FDA’s ongoing UDI implementation effort, download our whitepaper or watch our video overview.

Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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