🩺FDA Classifies Plazomicin Test System as Class II Device
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Plazomicin Test System
Summary
The Food and Drug Administration (FDA, Agency, or we) is classifying the plazomicin test system 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 plazomicin test system'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 the plazomicin test system as Class II (special controls), potentially streamlining regulatory processes and enhancing access for medical device manufacturers. This impacts compliance requirements and may lead to financial savings by reducing burdens previously associated with Class III devices.