date:Dec 24, 2018
iris Human Milk Analyzer test results in conjunction with clinical assessments (such as weight and growth) to inform their discussions with parents in creating a nutritional management plan for an infant or newborn.
The FDA reviewed the Miris Human Milk Analyzer test through the De Novo premarket review pathway, a regulatory pathway for low-to-moderate-risk devices of a new type. Along with this authorization, the FDA is establishing criteria, called special controls, to provide for the accurac