CDRH Encourages Migration Studies for In Vitro Diagnostic Devices

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. For example, migration may be appropriate when an assay is being transferred from a manual system to an automated or semi-automated instrument system, from a semi-automated instrument system to a fully automated instrument system or from one automated instrument system to another. Comments are due April 6.
Devices & Diagnostics Letter