Zdrowie i gospodarka · 08/08/2007

Guidance for Industry: Class II Special Controls Guidance Document: In Vitro Human Immunodeficiency Virus Drug Resistance Genotype Assay; Availability

The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Guidance for Industry: Class II Special Controls Guidance Document: In Vitro HIV Drug Resistance Genotype Assay," dated August 2007. The guidance document provides a means by which in vitro human immunodeficiency virus (HIV) drug resistance genotype assays may comply with special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule classifying the in vitro HIV drug resistance genotype assay into class II (special controls). The guidance announced in this notice finalizes the draft guidance entitled "Guidance for Industry: Premarket Notifications [510(k)s] for In Vitro HIV Drug Resistance Genotype Assays: Special Controls" dated August 2001.