FDA Proposes More Stringent UDI Requirements For Some Device 'Convenience Kits'
This article was originally published in The Gray Sheet
Under a draft guidance, more devices will require individual Unique Device Identification labels rather than being able to rely on a "convenience kit" exception in FDA's UDI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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The US agency's guidance says not every medical procedure kit is a so-called "convenience kit" whose contents can be exempted from Unique Device Identification labeling. The document also points out that devices used to replenish a first-aid kit should include UDI.
Just a little more than two weeks before the next Unique Device Identification compliance date, US FDA has granted two-year extensions to three product categories that raise particular complications for UDI labeling.
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