FDA Classifies Over-the-Counter SARS-CoV-2 Test as Class II Device
July 24, 2026
July 24, 2026
WASHINGTON, July 24 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has classified over-the-counter tests that detect SARS-CoV-2 from clinical specimens as Class II medical devices with special controls, establishing a permanent regulatory framework intended to ensure safety and effectiveness while expanding access to innovative diagnostic products.
The final amendment and final order take effect July 24, with the classification applicable b . . .
The final amendment and final order take effect July 24, with the classification applicable b . . .