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Home » CDRH Encourages Migration Studies for In Vitro Diagnostic Devices
CDRH Encourages Migration Studies for In Vitro Diagnostic Devices
January 9, 2009
Doing assay migration studies can be the least burdensome way for devicemakers to transfer a previously approved or licensed assay for a Class III in vitro diagnostic device to a new system, according to a draft CDRH guidance.