🍼FDA Classifies Breast Milk Macronutrients Test System for Safety
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Breast Milk Macronutrients Test System
Summary
The Food and Drug Administration (FDA, Agency, or we) is classifying the breast milk macronutrients 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 breast milk macronutrients 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 FDA's classification of the breast milk macronutrients test system into class II (special controls) implies that businesses manufacturing or desiring to manufacture this device will need to comply with specific regulatory requirements, which could streamline the approval process compared to class III. This regulatory change potentially reduces barriers and enhances market access.