Industry News, Medical Devices, Regulatory Affairs

USFDA extends deadline for UDI Compliance for Class II device labelers

US Food and Drug Administration have notified labelers of some Class II devices that the deadline for Unique Device Identification (UDI) compliance has been extended to September 201.8. This extension affects three broad categories of devices, all of which now have a compliance date of September 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 combinationpackaged together without individual labels; the FDA has extended compliance deadlines for these devices in order to finalize draft guidance the agency issued in early 2016 addressing how to properly define such products.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.

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