🦠FDA Classifies Fungal Nucleic Acid Detection Device to Class II
Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Fungal Nucleic Acids Directly in Respiratory Specimens
Summary
The Food and Drug Administration (FDA, Agency, or we) is classifying the device to detect and identify fungal 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 fungal 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.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The FDA's classification of the fungal nucleic acid detection device into Class II signifies reduced regulatory burdens, which may encourage innovation and market entry for businesses in medical devices. Compliance with specific controls and premarket notifications outlined in the text will be essential for manufacturers.