# 2026-12902: FDA Formally Classifies SARS-CoV-2 Antibody Tests

2026-12902, Medical Devices; Immunology and Microbiology Devices; Classification of the SARS-CoV-2 Serology Test, is a Federal Register rule from Health and Human Services Department, Food and Drug Administration published 2026-06-26, effective 2026-06-26; PRIA reads it as touching household money (as of 2026-07-03).

- Canonical: https://policyrisk.com/federal-register/2026-12902
- As of: 2026-07-03
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2026-12902
- Title: Medical Devices; Immunology and Microbiology Devices; Classification of the SARS-CoV-2 Serology Test
- Type: Rule
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 91 FR 38498
- Published: 2026-06-26
- Effective: 2026-06-26
- Comments close: not stated
- Significant: no
- Touches household money: yes
- Regulation identifier numbers: none
- Last updated: 2026-07-03

## In one line

FDA Formally Classifies SARS-CoV-2 Antibody Tests

## 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.

## Abstract

The Food and Drug Administration (FDA) is classifying the SARS-CoV-2 serology test into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the SARS- CoV-2 serology test. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

## Effects PRIA read

- SARS‑CoV‑2 Serology Reclassified to Class II: benefit, medium. 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…
- Tests Limited to Prescription Use: cost, low. 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‑c…
- New Special Controls and Emergency Duties: cost, medium. 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 tha…

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## Sources
- [2026-12902 on federalregister.gov](https://www.federalregister.gov/documents/2026/06/26/2026-12902/medical-devices-immunology-and-microbiology-devices-classification-of-the-sars-cov-2-serology-test)
- [2026-12902 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-06-26/pdf/2026-12902.pdf)

## Related
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- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2026-12902 (as of 2026-07-03).