CDRH Industry: Class II Special Controls Guideline: Dengue Virus Serological Reagents - Guideline for Industry and FDA Staff

A new guideline titled, "Class II Special Controls Guideline: Dengue Virus Serological Reagents" has recently been posted.  This special controls guideline was developed to support the classification into class II (special controls) of dengue (DEN) virus (DENV) serological reagents. DENV serological reagents are devices that consist of antigens and antibodies for the detection of DENV and DEN antibodies in individuals who have signs and symptoms of dengue fever (DF) or dengue hemorrhagic fever (DHF).  The detection aids in the clinical laboratory diagnosis of DF or DHF caused by DENV infection.  For more information, please see http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm399136.htm