Medical Devices; Immunology and Microbiology Devices; Classification of the Over-the-Counter Test To Detect SARS-CoV-2 From Clinical Specimens
Key claim: The FDA is classifying over-the-counter tests that detect SARS-CoV-2 from clinical specimens as class II devices subject to special controls to provide reasonable assurance of safety and effectiveness while reducing regulatory burdens and improving access.
Abstract
(Rule · Health and Human Services Department, Food and Drug Administration) The Food and Drug Administration (FDA) is classifying the over-the-counter test to detect SARS-CoV-2 from clinical specimens 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 over-the-counter test to detect SARS-CoV-2 from clinical specimens. 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
Classifying OTC SARS-CoV-2 tests as Class II with special controls creates a defined 510(k) pathway rather than requiring emergency use authorizations or premarket approval, which lowers barriers for manufacturers to market at-home COVID tests. For consumers, this supports continued availability of over-the-counter COVID testing as the public health emergency framework recedes. It fits a broader pattern of FDA down-classifying novel device types into Class II once performance criteria are established.