FDA extends UDI compliance date for Class II convenience kits and repackaged single-use devices

September 7, 2016
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The FDA has extended the compliance date for UDI labeling and data submission requirements to September 24, 2018 for the class II devices listed below. All other class II devices are subject to the September 24, 2016 UDI compliance date.

  1. Collections of two or more different devices packaged together in which the devices in the package are not individually labeled.
  2. Repackaged single-use devices

To view the official FDA Extension Letter click here.