HSV tests down-classified
This article was originally published in The Gray Sheet
Executive Summary
FDA 1proposed Jan. 9 to down-classify type 1 and 2 herpes simplex virus serological assays from Class III to Class II. More than 100 of the pre-amendment tests have been cleared under 510(k) applications since 1976, so there will be no practical difference in how the products are regulated once the reclassification goes through. The tests were assigned to Class III in 1982 because there was insufficient information about the herpes virus, an agency rep said...