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FDA Classifies Breast Milk Macronutrients Test System as Class II Device
May 09, 2025
WASHINGTON, May 9 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration (FDA) has finalized the classification of the breast milk macronutrients test system as a class II device, effective May 9, 2025.

This decision follows an extensive review of the device, which measures fat, protein, and carbohydrate content in human breast milk, aiding in the nutritional management of infants. Initially, devices like this would have been classified as class II . . .

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