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FDA Proposes More Stringent UDI Requirements For Some Device 'Convenience Kits'

Under a draft guidance, more devices will require individual Unique Device Identification labels rather than being able to rely on a "convenience kit" exception in FDA's UDI regulation. The agency says surgical instruments packaged together for convenience but used and reprocessed for different procedures are too difficult to track without separately affixed or marked UDIs.

In likely its last policy proposal of 2015, FDA is recommending more stringent Unique Device Identification labeling requirements to make it easier to track individual components of "convenience kits" if they are reused or used in different procedures.

When FDA developed its UDI rule in 2013, it made an exception for two or more medical devices packaged together...

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