★ Earth is ghetto★ 8 billion roommates, zero security deposit★ 1 in 3 households crushed by housing costs★ One hospital bill from bankruptcy★ Income inequality: above 0.40 and climbing★ Life expectancy: don't get too attached★ Air quality: questionable★ Political polarization: surging★ Homicide rates: location-dependent★ Now scoring 9 metrics — Gini coefficient added★ Recommendation: do not move in
earth is ghetto.
Policy Watchlist · Official Sources · US · UK · EU
USRuleOfficial ✓June 26, 2026· Federal Register

Medical Devices; Immunology and Microbiology Devices; Classification of the SARS-CoV-2 Serology Test

HealthMoneyImmigration
← Back to Policy Watchlist

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

← Full watchlist