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  5. In Vitro HIV Drug Resistance Genotype Assay - Class II Special Controls Guidance Document for Industry
  1. Guidance Documents (Medical Devices and Radiation-Emitting Products)

In Vitro HIV Drug Resistance Genotype Assay - Class II Special Controls Guidance Document for Industry

Read the Special Controls Document

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.