Source: Office of In Vitro Diagnostic Device Evaluation and Safety, January 5, 2009
This draft guidance presents a regulatory approach to gain FDA approval of Class III or certain licensed in vitro diagnostic devices in cases when a previously approved or licensed assay is migrating (i.e., transitioning) to another system for which the assay has not been previously approved or licensed. The focus of this guidance is on the study designs and performance criteria that should be fulfilled in order for a sponsor to utilize the migration study approach in support of the change. The guidance document describes information that FDA recommends sponsors include in a PMA (premarket approval application) supplement or a BLA (Biologics License Application). This guidance does not apply to immunohematology tests licensed by the Center for Biologics Evaluation and Research (CBER). This guidance can be used for 510(k) devices where the Replacement Reagent and Instrument Family Policy does not apply (e.g., nucleic acid amplification tests) and devices for which transition to a New System presents specific concerns, either because of the nature of the analyte and indications, or because of the specific technology used.