United States of America proposed classification of the Device to Detect and Identify Microbial Pathogen Nucleic Acids in Cerebrospinal Fluid The Food and Drug Administration (FDA) is classifying the device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid into class II (special controls). The special controls that will 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 microbial pathogen nucleic acids in cerebrospinal fluid'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. Product covered: Medical device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid HS code: 9018 Proposed date of adoption: 20-10-2017 Proposed date of entry into force: 20-10-2017 Final date for comments: NA |