🧪FDA Classifies Microbial Nucleic Acid Storage Devices
Medical Devices; Immunology and Microbiology Devices; Classification of the Microbial Nucleic Acid Storage and Stabilization Device
Summary
The Food and Drug Administration (FDA, Agency, or we) is classifying the microbial nucleic acid storage and stabilization device 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 microbial nucleic acid storage and stabilization device'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
$$ - Med
The regulation classifies microbial nucleic acid storage devices into Class II, which reduces regulatory burdens and streamlines the path for market access for businesses. Compliance with new special controls is necessary for manufacturers, impacting their operational and financial planning.