⚙️Voriconazole Test System Classification
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Voriconazole Test System
Summary
The Food and Drug Administration (FDA, Agency, or we) is classifying the voriconazole 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 voriconazole 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
$$$ - High
The regulation classifies the voriconazole test system as a Class II medical device, offering lower compliance burdens and thereby facilitating market entry for manufacturers. This creates opportunities for businesses in the medical device sector to innovate and potentially increase revenue. It also establishes requirements for safety and effectiveness assurance, impacting operational processes.