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

This article was originally published in The Gray Sheet

Executive Summary

Under a draft guidance, more devices will require individual Unique Device Identification labels rather than being able to rely on a "convenience kit" exception in FDA's UDI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.

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