Herpes virus special controls
This article was originally published in The Gray Sheet
Executive Summary
FDA finalizes a proposal to down-classify Type 1 and 2 herpes simplex virus serological assays from Class III to Class II medical devices in an April 3 final rule and special controls 1guidance (2"The Gray Sheet" Jan. 16, 2006, In Brief). HSV serological assays for other than Types 1 and 2 remain Class III devices...