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FDA permits marketing of a diagnostic test to aid in measuring nutrients in breast milk
date:Dec 24, 2018
y and reliability of tests intended to measure the nutritional content of human milk to aid in the nutritional management of certain infants. These special controls, when met along with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type. This action also creates a new regulatory classification, which means that subsequent devices of the same type, including the same intended use, may go through the FDAs 510(k) process, whereby devices can obtain m

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