Issue Date: April 25, 2013
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, Laboratory Tests, IVDs (In Vitro Diagnostic Devices)
Status: Final
Assay Migration Studies for In Vitro Diagnostic Devices: Guidance for Industry and FDA Staff
This guidance outlines FDA’s regulatory approach for approval of Class III in vitro diagnostic devices, as well as certain licensed or certain cleared in vitro diagnostic devices in cases, when a previously approved, licensed, or cleared assay is migrating (i.e., transitioning) to another system for which assay performance has not been evaluated by FDA. In this guidance the term “new system” refers to the system (assay, instrument, and software) to which the assay is migrating from a previously approved/licensed/cleared system. The term “old system” refers to the system (assay, instrument and software) which was approved/licensed/cleared from which the assay is migrating to a currently unapproved/unlicensed/uncleared system.
Download the Guidance Document
