FDA Classifies NGS HIV Drug Resistance Test Into Class II
Regulatory News | 06 February 2020 |
The US Food and Drug Administration (FDA) on Thursday issued a final order classifying next generation sequencing (NGS) HIV drug resistance genotyping assays used to aid in monitoring and treating HIV infections into Class II (special controls).
The final order follows a de novo classification request from Vela Diagnostics for its Sentosa SQ HIV Genotyping Assay last March and a decision in November to place the device into Class II. The final order on Thursday also codifies the classification under 21 CFR 866.3955 and provides a generic name for the device, “human immunodeficiency virus drug resistance genotyping assay using next generation sequencing technology.”
FDA says it has determined that the special controls laid out in the order, combined with general controls on the device, will provide a reasonable assurance of safety and effectiveness and “will enhance patients’ access to beneficial innovation.”
The final order identifies two risks posed by the assay and provides four mitigation measures for device makers to establish to ensure its safety and effectiveness and avoid automatic classification into Class III.
The two risks are the inaccurate detection of resistance mutation(s) and the incorrect interpretation of test results, which FDA says can be mitigated through device description and labeling measures:
FDA notes that, at this time, “HIV drug resistance genotyping assays using NGS technology are for prescription use only,” and do not have to meet requirements for providing adequate directions for use for laypersons.
Federal Register Notice
The final order follows a de novo classification request from Vela Diagnostics for its Sentosa SQ HIV Genotyping Assay last March and a decision in November to place the device into Class II. The final order on Thursday also codifies the classification under 21 CFR 866.3955 and provides a generic name for the device, “human immunodeficiency virus drug resistance genotyping assay using next generation sequencing technology.”
FDA says it has determined that the special controls laid out in the order, combined with general controls on the device, will provide a reasonable assurance of safety and effectiveness and “will enhance patients’ access to beneficial innovation.”
The final order identifies two risks posed by the assay and provides four mitigation measures for device makers to establish to ensure its safety and effectiveness and avoid automatic classification into Class III.
The two risks are the inaccurate detection of resistance mutation(s) and the incorrect interpretation of test results, which FDA says can be mitigated through device description and labeling measures:
| Identified Risks | Mitigation Measures |
| Inaccurate detection of resistance mutation(s) |
|
| Incorrect interpretation of test results |
FDA notes that, at this time, “HIV drug resistance genotyping assays using NGS technology are for prescription use only,” and do not have to meet requirements for providing adequate directions for use for laypersons.
Federal Register Notice
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