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...
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Regulatory News In Brief
Herpes tests: FDA is amending a 2007 regulation that downclassified herpes simplex virus (HSV) serological assays to Class II to remove any reference to HSV assays other than type 1 and type 2 tests. In 1983, FDA classified the pre-amendment devices as Class III, then downclassified type 1 and type 2 tests in 2007 (1"The Gray Sheet" Jan. 16, 2006). Other HSV serological tests remained Class III, but because there are no other types of HSV tests on the market, FDA issued the Aug. 25 rule to prevent confusion. HSV assays were one of 27 types of pre-amendment devices that FDA had yet to downclassify or require PMAs for (2"The Gray Sheet" April 13, 2009). HSV test makers include Quest Diagnostics and Bio-Rad
Herpes virus special controls
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...
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