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Regulatory Focus™ > News Articles > 2020 > 2 > FDA Classifies NGS HIV Drug Resistance Test Into Class II

FDA Classifies NGS HIV Drug Resistance Test Into Class II

Posted 06 February 2020 | By Michael Mezher 

FDA Classifies NGS HIV Drug Resistance Test Into Class II

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:
Identified Risks Mitigation Measures
Inaccurate detection of resistance mutation(s)
  • Device description information, including performance characteristics and performance studies in labeling;
  • Device description validation procedures and performance studies meeting acceptance criteria;
  • Device limitations in labeling for genetic mutation detection;
  • Device description information, performance characteristics and performance studies in labeling.
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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