FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; GASTROENTEROLOGY-UROLOGY DEVICES; CLASSIFICATION OF THE LAPAROSCOPIC GASTROINTESTINAL SIZING TOOL

WASHINGTON, Aug. 21 -- Food and Drug Administration has issued a rule called: Medical Devices; Gastroenterology-Urology Devices; Classification of the Laparoscopic Gastrointestinal Sizing Tool.

The rule was published in the Federal Register on Aug. 21 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 laparoscopic gastrointestinal sizing tool 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 classification of the laparoscopic gastrointestinal sizing tool. We are taking this action because we have deter...