FDA has extended the compliance date for UDI label and GUDID submission requirements to September 24, 2018, for certain class II devices!! FDA has also clarified that the UDI and GUDID compliance date for certain device constituents of certain combination products will be September 2018. The UDI and GUDID extension applies to the below devices and device constituents.

1. Collections of two or more different devices packaged together in which the devices in the package are not individually labeled.
   FDA is extending the compliance date for UDI label and GUDID submission requirements for collections of two or more different class II (or class II and class I) devices packaged together in which each device in the package is not individually labeled with a UDI to September 24, 2018. This extension does not apply to collections of devices that include one or more devices that are implantable, life-sustaining or life-supporting.
2. Repackaged single-use device
   The compliance date for Single-use devices (other than devices that are implantable, life-sustaining or life-supporting) that are not individually labeled with a UDI is extended to September 24, 2018
3. Device Constituents
   For device constituents other than devices that re implantable, life-sustaining or life-supporting the compliance date for UDI and GUDID has been extended September 24, 2018

IFor more information about the topic please read FDA Letter for Device Labelers.

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