FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES; CLASSIFICATION OF THE LYSOSOMAL STORAGE DISORDER NEWBORN SCREENING TEST SYSTEM

WASHINGTON, June 26 -- Food and Drug Administration has issued a rule called: Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Lysosomal Storage Disorder Newborn Screening Test System.

The rule was published in the Federal Register on June 26 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA, the Agency, or we) is classifying the lysosomal storage disorder newborn screening 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 lysosomal storage disorder newborn screening test system's class...