FDA Extends UDI Deadline for Convenience Kit and Repackaged Device Labelers

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FDA Extends UDI Deadline for Convenience Kit and Repackaged Device Labelers

Labelers of some Class II devices have been notified by the FDA that their deadline for Unique Device Identification (UDI) compliance has been extended  to September 2018.

The new compliance date for UDI labeling, as well as Global Unique Device Identification Database (GUDID) compliance,  is September 24, 2018. The following three categories of devices are involved:

  • “Convenience kits”:  two or more devices (Class II or Class I and II in combination) packaged together without individual labels. Compliance deadlines for these devices have been extended in order to finalize the 2016 draft guidance that changed the definition of such products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.

Devices included  in the above categories and serving  an implantable, life-sustaining or life-supporting purpose are not affected by the deadline extension.

 

http://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM519346.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery