The Food and Drug Administration (FDA) is classifying the SARS-CoV-2 serology test into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the SARS- CoV-2 serology test. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
US Federal Register - FDA Rules · June 26, 2026
FDA Classification of SARS-CoV-2 Serology Test as Class II Medical Device
Original title: Medical Devices; Immunology and Microbiology Devices; Classification of the SARS-CoV-2 Serology Test
FDA classifies SARS-CoV-2 serology tests into class II with special controls, establishing the regulatory pathway for this device type.
Published by US Federal Register - FDA Rules. HealthSignal links to the original document; the summary above is extracted from the source text.