FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; GASTROENTEROLOGY-UROLOGY DEVICES; CLASSIFICATION OF THE ENDOSCOPIC LIGHT-PROJECTING MEASURING DEVICE

WASHINGTON, June 22 -- Food and Drug Administration has issued a rule called: Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Light-Projecting Measuring Device.

The rule was published in the Federal Register on June 22 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA) is classifying the endoscopic light-projecting measuring device 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 light-projecting measuring device. We are taking this action because we have determined that cla...