FDA Formally Classifies SARS-CoV-2 Antibody Tests
Published Date: 6/26/2026
Rule
Summary
The FDA is officially putting the COVID-19 antibody (serology) test into a safer, easier-to-manage category called Class II, starting June 26, 2026. This change helps make sure the tests work well and are safe, while also making it simpler for companies to bring new and better tests to patients. If you’re a test maker or user, expect smoother rules and better access without extra costs or delays.
Analyzed Economic Effects
3 provisions identified: 1 benefits, 2 costs, 0 mixed.
SARS‑CoV‑2 Serology Reclassified to Class II
The FDA officially classified SARS‑CoV‑2 serology tests as Class II (special controls) effective June 26, 2026; the classification was applicable on May 5, 2023. As Class II devices, they are subject to premarket notification (section 510(k)) rather than automatic Class III premarket approval, and a De Novo-classified device can serve as a predicate for future 510(k) submissions.
New Special Controls and Emergency Duties
Manufacturers of SARS‑CoV‑2 serology tests must meet detailed special controls including labeling, multisite clinical and analytical studies, design verification/validation, software and cybersecurity documentation, lot‑level studies, and risk‑monitoring protocols. If FDA notifies manufacturers that characterized samples are available during certain events, testing must be performed within 30 days and results included in labeling within 60 days and retained in labeling for 3 years; FDA may request evaluations be submitted within 48 hours.
Tests Limited to Prescription Use
At the time of classification, SARS‑CoV‑2 serology tests are for prescription use only and must meet prescription labeling requirements under 21 CFR 809.10. This means these antibody tests are intended to be used under a healthcare provider's prescription rather than as over‑the‑counter direct‑to‑consumer tests.
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