Here are five key notes:
1. The FDA extended the UDI compliance deadline for device convenience kits and repackaged single-use devices.
2. Companies had to implement UDI compliance for Class III devices in 2014 and for implantable, life-supporting and life-sustaining devices in 2015.
3. All Class II devices not mentioned in the FDA’s extension must comply with UDI standards by Sept. 24, 2016.
4. The FDA extended the compliance for the devices with different formats and packaging than the other Class II devices.
5. The extension is in response to stakeholder concerns and questions about UDI compliance for these devices.
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