USRuleOfficial ✓June 26, 2026· Federal Register
Medical Devices; Immunology and Microbiology Devices; Classification of the SARS-CoV-2 Serology Test
What happened
The Food and Drug Administration (FDA) is classifying the SARS-CoV-2 serology test into class II (special controls). This action, signed by Donald Trump, is effective June 26, 2026, with the classification applicable since May 5, 2023. The FDA made this decision to provide a reasonable assurance of the device's safety and effectiveness.
Why it matters
This reclassification aims to make these COVID-19 antibody tests more accessible to patients. By reducing regulatory hurdles, it promotes innovation in medical devices. This encourages new tests to come to market more easily.
Who it affects
- ›Patients needing SARS-CoV-2 serology tests
- ›Manufacturers of SARS-CoV-2 serology tests
- ›Medical device innovators
- ›Healthcare providers using these tests
Receipts
The receipts are official. The summary is ours.
Read on Federal Register ↗Summaries are generated from the official text and may simplify or omit nuance. The official document is the source of truth.
More from US
USRuleOfficial ✓
U.S. Ecology Nevada, Inc. High Mercury Subcategory Wastes Land Disposal Restrictions VarianceFederal Register·Jun 26, 2026
USRuleOfficial ✓
Air Plan Approval; Ohio; Source-Specific Non-CTG RACT and SIP Strengthening for OhioFederal Register·Jun 26, 2026
USRuleOfficial ✓
Medical Devices; Clinical Chemistry and Toxicology Devices; Classification of the Prognostic Test for Development or Progression of PreeclampsiaFederal Register·Jun 26, 2026