FDA Loosens Controls on Dengue Virus Detection Devices

The Food and Drug Administration reclassifying dengue virus serological reagents as Class II devices that do not require premarket approval, in an order issued May 30 that took effect April 8. The devices, which consist of antigens and antibodies for the detection of dengue virus in people who show symptoms, had been classified in Class III, and required the filing of a premarket approval application before distribution. The devices will be subject to premarket notification requirements as well as certain extra "special controls" related to performance characteristics, testing, and labeling.