Medical Devices; Immunology and Microbiology Devices; Classification of the Over-the-Counter Test To Detect SARS-CoV-2 From Clinical Specimens
What happened
The Food and Drug Administration (FDA) classified over-the-counter tests for detecting SARS-CoV-2 from clinical specimens into class II (special controls). This final order, signed by Donald Trump and effective July 24, 2026, codifies the classification into 21 CFR 866.3984, following a June 6, 2023 order to the requester. This action reclassified the device from an automatic class III assignment through a De Novo classification process.
Why it matters
This classification is intended to assure the safety and effectiveness of these tests for consumers. It also aims to improve patient access to innovative diagnostic devices by reducing regulatory hurdles for manufacturers.
Who it affects
- ›Patients testing for SARS-CoV-2 at home
- ›Manufacturers of over-the-counter COVID-19 tests
- ›Device sponsors developing diagnostic tests
- ›Healthcare providers and clinical laboratories
- ›General public seeking COVID-19 testing
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.