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FDA News In Brief

This article was originally published in The Gray Sheet

Executive Summary

Factor V Leiden: Effective April 15, FDA 1Factor V Leiden DNA mutation detection system final rule formalizes Class II (special controls) status for the genetic tests intended to aid in diagnosis of patients thought to have thrombophilia. The final rule and accompanying 2special controls guidance - among the first product-specific guidance the IVD office has issued for genetic tests - was prompted by Roche's de novo approval Dec. 17 (3"The Gray Sheet" Dec. 22, 2003, p. 26). Stand-alone Factor V tests for general or prenatal screening are outside the scope of the rule and guidance...
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