🧬FDA Classifies New Nucleic Acid Detection Device for STIs
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)
Summary
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.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The text outlines the FDA’s classification of a medical device, which falls under regulatory requirements for businesses in the medical and healthcare sectors. Compliance with new special controls impacts operational processes and market access.