Federal Register Proposed rule: FDA is proposing to reclassify herpes simplex virus (HSV) (Types 1 and/or 2) serological assays from Class 3 (premarket approval) to Class 2 (special controls). HSV serological assays (Types 1 and/or 2) are intended for testing specimens from individuals who have signs and symptoms of infection consistent with HSV 1 and/or 2 or for determining if an individual has been previously infected with HSV 1 and/or 2, as well as for providing epidemiological information about these infections.

The detection of HSV antibodies, in conjunction with other clinical laboratory findings, aids in the clinical laboratory diagnosis of an infection by HSV 1 and/or 2. FDA is proposing this reclassification on its own initiative based on new information.

FDA is also making available a draft guidance that would serve as the special control if the agency reclassifies the device.

To download the guidance, click here. To view this proposed rule, click here.