The FDA issued a draft gudance entitled “Flow Cytometric Devices” dated 14-Oct-2014. Section 5 of this guidance addresses softwrae used in the device and discusses regualtory clearance with the associated reagents and instrumentation as well as other information needed. The full guidance is at the link provided and was issues jointly by the Office of In Vitro Diagnositcs Division of Immunology and Hematology and the Center for Biologics Evaluation and Research.