Business · 11/06/2026

FDA Classifies Point-of-Care SARS-CoV-2 Testing Device as Class II (Special Controls)

The FDA has classified a simple point-of-care device for detecting SARS-CoV-2 viral targets from clinical specimens in near-patient settings as Class II, with special controls, to ensure safety and effectiveness, and to reduce regulatory burdens, ultimately enhancing patient access to innovative devices.