FDA Permits Marketing of New Diagnostic Test That Measures Nutrients in Breast Milk

As matured human beings, we generally have a plethora of options when it comes to where we receive our nutrients, but for those in the fragile first 12 months of life, the choices are severely limited. Basically, the choices come down to either the less nutrient sufficient formula, or the more nutrient complex breast milk. So those who desire a more nutrient-rich diet for their infant will generally have to choose breast milk.

Recently the U.S. Food and Drug Administration permitted marketing of the Miris Human Milk Analyzer after reviewing it through the De Novo premarket review pathway, a regulatory pathway for new low-to-moderate-risk devices. This device and diagnostic test is designed to examine breast milk in order to accurately measure its nutrient composition. Breast milk composition will often vary depending on the individual, and so a test which can examine their nutritional value can be a valuable guide. The findings from this test can include concentrations of fat, carbohydrate, protein, total solids, and energy; providing healthcare professionals and parents of newborns with vital information.

The Miris Human Milk Analyzer is a prescription device used by professionals that operates by analyzing samples of human milk through an infrared spectroscopy system. This system will produce quantitative measurements of the contents contained in the milk. There are conditions that limit the information taken by the machine though, such as an interference from medication that is generally used by nursing mothers.

Courtney Lias is a Ph.D. director of the Division of Chemistry and Toxicology Devices in the FDA’s Center for Devices and Radiological Health. Lias states “For the first time, doctors have access to a test to help analyze the nutrients in breast milk. While this test is not for everyone, it has the potential to aid parents and healthcare providers, mainly in a hospital setting, in better assessing the nutrient needs of certain babies who are not growing as expected.”

The Miris Human Milk Analyzer can help lead to many infants receiving the care and nutrients they need in order to grow strong and healthy. Infants born prematurely or with any number of health conditions will often require some specific nutritional needs, and this test can help professionals and parents plan a more exact feeding strategy. Lias remarks “Breast milk provides many health benefits to infants, and for many babies, it can meet their early nutritional needs. But some infants — including those who may be born preterm or have certain health conditions — may need additional nutrients in order to support their optimal growth.” This fact alone supports the FDA’s choice to support the marketing of the Miris Human Milk Analyzer.

The FDA has always been an agency saddled with the responsibility to protect and promote wellness and positive public health. They have authority over a number of categories such as drugs, vaccines, cosmetics, supplements, food, and medical equipment. The FDA reviewed data submitted by the sponsor of 112 samples human milk and found that the values obtained by the independent methods and the values tested by the machine provided similar results. This was enough data to show that the Miris Human Milk Analyzer test can efficiently determine levels of protein, fat, and carbohydrate.

Along with the authorization to market this device, the FDA is also establishing criteria in order to assure the accuracy and reliability of tests with the proposed of measuring the nutritional content of breast milk. These special controls, in conjunction with general controls, will aid in the assurance of safety and efficiency for tests such as the Miris Human Milk Analyzer test. This creates a new regulatory classification, which allows devices intended for the same use to go through the FDA’s 510(k) process to obtain marketing authorization by demonstrating proficiency.

While the FDA has granted marketing authorization of the Miris Human Milk Analyzer test to Miris AB, they also note that healthcare professionals are still asked to carefully evaluate its results in conjunction with clinical assessments including weight and growth when informing parents of nutritional management plans for their newborn or infant. Basically, this implies that professionals must still be thorough in their findings even with the machines assistance.

Looking ahead the Miris Human Milk Analyzer test could be the start to a number of new and progressive nutrient measuring devices that can assist in creating a healthier world. For now, though, this device will be the start in helping provide for our future generations.

Jeffrey Newman represents whistleblowers. Contact us today for more information.