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FDA Guidance News In Brief

This article was originally published in The Gray Sheet

Executive Summary

HIV drug resistance testing: Aug. 8 guidance describes two pathways - one involving only analytical testing and the other combining analytical and clinical testing - for 510(k) clearance of assays that detect HIV mutations associated with drug resistance. The Class II special controls guidance accompanies a rule reclassifying HIV drug resistance genotype assays from Class III to II...
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