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See today's BioWorld MedTech
Home » Stakeholders see scope issues with FDA’s proposal to apply class II designation to HIV tests
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Stakeholders see scope issues with FDA’s proposal to apply class II designation to HIV tests

April 30, 2020
By Mark McCarty
The COVID-19 pandemic has gripped the conversation regarding diagnostic and surveillance testing, but stakeholders nonetheless saw fit to populate the docket for the FDA’s proposal to down-classify tests for the human immunodeficiency virus (HIV) to class II. One of the themes of the feedback was that the proposal excludes a few key items, such as quantitative nucleic acid tests and testing for viral load monitoring, leaving the FDA with some difficult decisions to make.
BioWorld MedTech Regulatory Infection Diagnostics FDA

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