Zdrowie i gospodarka · 24/07/2026

FDA Classifies Over-the-Counter SARS-CoV-2 Test as Class II Device

The FDA has classified an over-the-counter test to detect SARS-CoV-2 from clinical specimens as a Class II device, which will provide a reasonable assurance of safety and effectiveness, and is expected to reduce regulatory burdens and enhance patient access to innovative devices.