CDRH Industry: Flow Cytometric Devices - Draft Guidance for Industry and FDA Staff

A draft guidance has been posted regarding Flow Cytometric Devices.  This guidance addresses certain issues that arise in premarket submissions for flow cytometric devices used as in vitro diagnostic devices for leukocyte immunophenotyping and provides suggestions on the content of submissions for these types of devices.  To view the draft guidance, please see: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM418205.pdf