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.
Your PRIA Score
Personalized for You
How does this regulation affect your finances?
Sign up for a PRIA Policy Scan to see your personalized alignment score for this federal register document and every other regulation we track. We analyze your financial profile against policy provisions to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-12899 — Medical Devices; General Hospital and Personal Use Devices; Classification of the Foam or Gel Chemical Sterilant/High Level Disinfectant
The FDA is officially putting foam or gel chemical sterilants and high-level disinfectants into Class II, meaning they’ll have special safety rules but fewer red tape hurdles. This change helps companies bring safer, innovative cleaning products to hospitals and homes faster, starting June 26, 2026. If you make or use these devices, expect smoother approvals and better access without extra costs or delays.
2026-12959 — Determination That Prednisolone Tablet, 5 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The FDA has decided that the 5 mg prednisolone tablet wasn’t taken off the market because of safety or effectiveness problems. This means generic drug makers can keep getting approval to sell their versions of this medicine, as long as they follow the rules. Patients and pharmacies can expect continued access to affordable generics without any interruptions or extra costs.
2026-12937 — List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Extension of Comment Period
The FDA is giving folks more time to share their thoughts on whether certain medicines like semaglutide, tirzepatide, and liraglutide should be allowed for special compounding by outsourcing drug makers. This extension means anyone interested has until July 30, 2026, to weigh in. It affects drug makers, healthcare pros, and patients waiting for these meds, with no immediate cost changes but plenty of chances to influence future drug availability.
2026-12906 — Revocation of Three Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability
The FDA has officially ended emergency use for three COVID-19 test kits from BD, InBios, and Roche as of early 2026. This means these specific tests are no longer authorized for quick COVID-19 detection or diagnosis. If you or your organization used these tests, it’s time to switch to other approved options—no extra costs or penalties, just a smooth transition.
2026-12933 — Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Extension of Effective Date of Final Resolution of Drug Efficacy Study Implementation 7661
The FDA is giving itself 90 more days—until September 24, 2026—to finish reviewing important feedback about certain estrogen-androgen combo drugs like Syntest tablets. This means the final decisions about these drugs’ approval are on hold a bit longer, affecting drug makers and patients waiting for updates. No extra costs are mentioned, just more time to get it right!
2026-12900 — Medical Devices; Clinical Chemistry and Toxicology Devices; Classification of the Prognostic Test for Development or Progression of Preeclampsia
The FDA is officially putting the test that predicts preeclampsia risk into a safer, easier-to-get category called Class II. This change helps make sure the test works well and is safe, while also making it simpler for patients to access this important health tool. The new rules took effect on June 26, 2026, but the classification has been in place since May 18, 2023, helping companies save time and money on approvals.
Previous / Next Documents
Previous: 2026-12901 — Medical Devices; Neurological Devices; Classification of the Computerized Behavioral Therapy Device for the Treatment of Fibromyalgia Symptoms
The FDA is officially classifying a computerized behavioral therapy device for fibromyalgia symptoms as a Class II device, meaning it meets safety and effectiveness standards with special controls. This change helps patients get easier access to this innovative treatment by reducing some regulatory hurdles. The new classification is effective June 26, 2026, and could speed up how quickly these devices reach the market without extra costs.
Next: 2026-12903 — Medical Devices; General and Plastic Surgery Devices; Classification of the Breast Implant Suction Retrieval System
The FDA has officially placed the breast implant suction retrieval system into Class II, meaning it now has special safety rules but fewer regulatory hurdles. This change helps make the device safer and easier to get to patients without unnecessary delays. The new classification took effect on June 26, 2026, and could speed up innovation while keeping costs in check for makers and users.