HHS FDA Classifies Point-of-Care COVID-19 Test Devices Into Class II Category
June 12, 2026
June 12, 2026
WASHINGTON, June 12 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has issued a final order classifying simple point-of-care devices that directly detect SARS-CoV-2 viral targets from clinical specimens in near-patient settings as Class II medical devices subject to special controls. The action is intended to provide a reasonable assurance of safety and effectiveness while reducing regulatory burdens for manufacturers developing diagnostic technologies u . . .