FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES; CLASSIFICATION OF THE SETMELANOTIDE ELIGIBILITY GENE VARIANT DETECTION SYSTEM

WASHINGTON, April 22 -- Food and Drug Administration has issued a rule called: Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Setmelanotide Eligibility Gene Variant Detection System.

The rule was published in the Federal Register on April 22 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 setmelanotide eligibility gene variant detection 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 classification of the setmelanotide eligibility gene variant detecti...