FDA Lowers Hurdles for At-Home COVID Tests
Published Date: 7/24/2026
Rule
Summary
The FDA is officially putting over-the-counter COVID-19 tests into a safer, easier-to-manage category called Class II, starting July 24, 2026. This change helps make sure these tests work well and are safe, while also making it simpler for companies to bring new tests to you. If you’re a test maker or a user, expect better access and less red tape, with no extra costs announced.
Analyzed Economic Effects
5 provisions identified: 2 benefits, 2 costs, 1 mixed.
Manufacturers Must Meet Special Controls
If you make OTC SARS-CoV-2 tests, your device must comply with the listed special controls and submit a premarket notification under section 510(k); FDA has not exempted these tests from 510(k). The special controls include detailed labeling, design verification and validation, clinical and analytical studies, software documentation, and risk analysis.
OTC COVID Tests Reclassified to Class II
The FDA is classifying over-the-counter (OTC) tests that detect SARS-CoV-2 as Class II (special controls) effective July 24, 2026 (classification applicable June 6, 2023). The agency says this will provide reasonable assurance of safety and effectiveness and will help enhance patient access by reducing regulatory burdens compared with automatic class III assignment.
Clinical Study Performance Thresholds
For OTC SARS-CoV-2 tests, clinical studies must be prospective, multisite, and representative of intended users and circulating strains, and the lower bound of the two-sided 95% confidence interval of the positive percent agreement (PPA) with a molecular comparator must be greater than 70 percent.
Emergency Variant Testing and Posting Timelines
If FDA provides characterized samples or declares an HHS public health emergency for SARS-CoV-2, manufacturers must test devices with those samples within 30 days of FDA notice and, within 60 days of notice and continuing until 3 years, post emergency analytical reactivity testing results in tabular format on the required public website.
Stronger Labeling and Public Website Rules
OTC SARS-CoV-2 tests must include specified labeling (intended use, specimen types, limitations, warnings, age or days-post-symptom-use limits) and a prominent hyperlink on product labeling to a manufacturer website with instructions, FAQs, and performance data in language appropriate for the intended user.
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