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

摘要

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. Following the effective date of a final rule classifying the device, any manufacturer submitting a 510(k) premarket notification for an in vitro HIV drug resistance assay will need to address the issues covered in this special controls guidance. The manufacturer must show that its device meets the recommendations of this guidance or in some other way provides equivalent assurances of safety and effectiveness.