Draft Guidance for Industry and Food and Drug Administration Staff; Assay Migration Studies for In Vitro Diagnostic Devices; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Assay Migration Studies for In Vitro Diagnostic Devices." This draft guidance presents a least burdensome regulatory approach to gaining FDA approval of Class III or certain licensed in vitro diagnostic devices in cases when a previously approved assay is migrating (i.e., transitioning) to a New System for which the assay has not been previously approved or licensed.