US FDA lays out UDI tips and timelines for direct-marking of reprocessed devices
This article was originally published in SRA
Reprocessed and re-used life-sustaining and life-supporting devices in the US - regardless of their classification - will need to have unique device identifiers (UDI) directly marked on them by September 2016, according to a new Food and Drug Administration draft guidance which lays out a timeline that would require all other necessary devices to follow direct marking requirements by the end of 20201,2.
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