Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect Nucleic Acids From Non-Viral Microorganism(s) Causing Sexually Transmitted Infections and Associated Resistance Marker(s)

The Food and Drug Administration (FDA, Agency, or we) is classifying the device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections and associated resistance marker(s) 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 the device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections and associated resistance marker(s)'s classification. We are taking this action because we have determined that classifying the device into class II (special controls) 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.