Draft “Guidance for Industry: Premarket Notifications [510(k)s] for In Vitro HIV Drug Resistance Genotype Assays;” Availability

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The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled "Guidance for Industry: Premarket Notifications [510(k)s] for In Vitro HIV Drug Resistance Genotype Assays" dated August 2001. In Vitro HIV Drug Resistance Genotype Assays are Class III devices that FDA is considering reclassifying as Class II, with special controls. This document describes such special controls, in draft, which would be intended to assist manufacturers of In Vitro HIV Drug Resistance Genotype Assays to file premarket notifications [510(k)s] instead of premarket approval applications (PMAs) for this device.