FDA Eases Rules for Simple COVID Rapid Tests
Published Date: 6/11/2026
Rule
Summary
The FDA is officially putting simple COVID-19 rapid test devices into a safer, easier-to-manage category called Class II. This change means these tests can get to patients faster and with fewer hoops to jump through, while still making sure they work well and stay safe. Starting June 11, 2026, companies making these tests will follow new rules that help speed up innovation without extra costs.
Analyzed Economic Effects
4 provisions identified: 2 benefits, 2 costs, 0 mixed.
New study, labeling, and submission requirements
Manufacturers must submit a premarket notification (510(k)) for these Class II tests and meet detailed special controls in 21 CFR 866.3982, including labeling elements, intended use limited to respiratory specimens, and clinical and analytical study requirements. Clinical evidence must include a prospective multisite study with geographically diverse samples compared to an FDA-accepted molecular comparator, and performance criteria requiring the lower bound of the two-sided 95% confidence interval for positive percent agreement to be ≥80% (or ≥70% with additional mitigations).
Faster patient access to COVID tests
The FDA has put simple point-of-care COVID-19 rapid tests into Class II, which the agency says will enhance patients' access to these tests by reducing regulatory burdens. The order is effective June 11, 2026, and the classification was applicable on March 8, 2023.
Easier market path for device makers
FDA classified simple near-patient SARS-CoV-2 tests as Class II, allowing these devices to serve as predicates for future devices and enabling sponsors to use the less-burdensome 510(k) pathway instead of premarket approval. The order is effective June 11, 2026, and the classification was applicable on March 8, 2023.
Emergency testing and rapid reporting duties
If certain actions under section 564(b)(1)(A)-(D) occur or HHS declares a public health emergency under section 319(a), manufacturers must test devices with FDA‑provided characterized samples within 30 days of notification and must include results in device labeling within 60 days; those labeling entries must remain for 3 years. FDA may also request evaluation results to be submitted within 48 hours.
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