FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES; CLASSIFICATION OF THE BREAST MILK MACRONUTRIENTS TEST SYSTEM

WASHINGTON, May 9 -- Food and Drug Administration has issued a rule called: Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Breast Milk Macronutrients Test System.

The rule was published in the Federal Register on May 9 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

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 determine...