Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Microorganisms and Associated Resistance Marker Nucleic Acids Directly in Respiratory Specimens
Information
Type
Rule
Regulated products
Medical Devices
Published
March 14, 2019
Last updated
March 14, 2019
Description
Document number 2019-04719. The Food and Drug Administration (FDA or we) is classifying the device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory 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 the device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens 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.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)