Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Nucleic Acid Targets Including SARS-CoV-2 in Respiratory Specimens
Information
Type
Rule
Regulated products
Medical Devices
Published
August 16, 2024
Last updated
August 16, 2024
Description
Document number 2024-18266. The Food and Drug Administration (FDA, Agency, or we) is classifying the device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target 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 the device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test'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.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)