September 9, 2016
FDA extends UDI compliance date for certain Class II devices
Editor's Note
In a September 6 letter to device labelers, the Food and Drug Administration (FDA) said it is extending unique device identifier (UDI) requirements for certain Class II devices from September 24, 2016 to September 24, 2018.
The extension applies to repackaged single-use devices and device convenience kits.
The FDA says the same compliance date also applies to device constituents for certain combination products.
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