Medical Devices; Immunology and Microbiology Devices; Classification of the SARS-CoV-2 Serology Test
Key claim: The FDA is classifying the SARS-CoV-2 serology test as a Class II medical device subject to special controls to provide reasonable assurance of safety and effectiveness while reducing regulatory burdens.
Abstract
(Rule · Health and Human Services Department, Food and Drug Administration) 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.
Why this matters
Class II classification with special controls establishes a defined regulatory pathway for SARS-CoV-2 serology tests, letting manufacturers rely on 510(k) clearance rather than case-by-case premarket review. For providers and labs, this stabilizes the post-emergency-use framework for antibody testing, clarifying what tests can remain on or enter the market and under what performance standards.