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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
In this document, we describe two pathways for you to seek clearance of your assay as a Class II device for detecting HIV mutations. Under the first pathway, you would demonstrate the analytical sensitivity of your test in identifying mutations in Tables A through E, below. An applicant following the second pathway would develop a combination of analytical data and clinical data showing the performance of the test as an aid in treatment of subjects with HIV. We recognize that as the field progresses, additional mutations may become widely recognized as clinically significant. We have based the information in this document on current science.

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