FDA classifies over-the-counter COVID-19 tests as Class II devices
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The Food and Drug Administration (FDA) has issued a final rule classifying over-the-counter tests used to detect SARS-CoV-2 (the virus that causes COVID-19) as Class II medical devices.
Why it matters: This is a technical administrative change that sets the formal regulatory category for home COVID-19 tests, ensuring they meet specific safety standards before they reach consumers.
Who it affects
- Manufacturers of over-the-counter COVID-19 test kits
This information comes from the FDA via the Federal Register; readers should consult the official document before relying on it for regulatory compliance.
Agency: Health and Human Services Department, Food and Drug Administration
Source: Federal Register — read the official document