Issue Date: 03/01/2011
Issued By: Office of Medical Products and Tobacco, Center for Biologics Evaluation and Research
We, FDA, are issuing this guidance document in conjunction with a Federal Register final rule reclassifying from class III to class II the in vitro HIV drug resistance genotype assay, an in vitro diagnostic device (IVD), to use in detecting HIV genomic mutations that confer resistance to specific antiretroviral drugs, as an aid in monitoring and treating HIV infection. This guidance document serves as the special control to support the reclassification. Special controls, when combined with general controls, provide reasonable assurance of the safety and effectiveness of the device.