WASHINGTON, May 28 -- Food and Drug Administration has issued a rule called: Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Suturing Device for Altering Gastric Anatomy for Weight Loss.
The rule was published in the Federal Register on May 28 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: The Food and Drug Administration (FDA) is classifying the endoscopic suturing device for altering gastric anatomy for weight loss 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 endoscopic suturing device for altering gastric anatomy...