The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

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


Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA,

Document Type:
Guidance for Industry
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.

Go back

GMP Conferences by Topics

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information