US FDA lays out tips, sets deadlines for UDI direct-marking of reprocessed devices
This article was originally published in Clinica
Executive Summary
Reprocessed and re-used life-sustaining and life-supporting devices, regardless of their classification, will need to have unique device identifiers (UDI) directly marked on them by September 2016 according to a new FDA draft guidance which lays out a timeline that would require all other necessary devices follow direct marking requirements by the end of 2020.