UDI Resources

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September 24, 2018 is:

• The UDI compliance date for direct marking of class II devices
• The date the UDI will be required for most kits with at least one class III, I/LS/LS or class II device within the kit
• The date the UDI will be required for most co-packaged and cross-labeled combination products with a device constituent
• The expiration date of the 801.30(a)(1) (three year "grandfather") I/LS/LS inventory exception