Medical Devices; Immunology and Microbiology Devices; Classification of the System for Detection of Nucleic Acid From Non-Viral Microorganism(s) Causing Sexually Transmitted Infections Using Home-Collected Specimens
Key claim: The FDA is placing at-home tests that detect non-viral sexually transmitted infections from self-collected samples into a moderate-risk (class II) category with special controls, making it easier for manufacturers to bring those tests to market.
Abstract
(Rule · Health and Human Services Department, Food and Drug Administration) The Food and Drug Administration (FDA) is classifying the system for detection of nucleic acid from non-viral microorganism(s) causing sexually transmitted infections using home-collected 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 system for detection of nucleic acid from non-viral microorganism(s) causing sexually transmitted infections using home-collected specimens. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the 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
Reclassifying at-home STI nucleic acid tests as Class II with special controls lets manufacturers use the 510(k) pathway instead of PMA, which typically lowers the cost and timeline to bring new home-collection STI tests to market. For patients, this can expand access to private, at-home screening for infections like chlamydia and gonorrhea without a clinic visit. It is one of a series of recent FDA device classification actions moving diagnostics toward lower-burden regulatory pathways.