FDA Revises Special Controls for Herpes Detection Assays

In light of additional safety and efficacy information, the FDA wants to amend the special controls for Class II herpes simplex virus (HSV) Type 1 and 2 serological assay devices. The agency has issued a proposed rule for the new special controls, which are described in a new draft guidance. Comments on the rule are due by Nov. 29, and comments on the guidance should be submitted by Dec. 27.
Devices & Diagnostics Letter