FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; GASTROENTEROLOGY-UROLOGY DEVICES; CLASSIFICATION OF THE INGESTIBLE GASTROINTESTINAL BLOOD DETECTION CAPSULE

WASHINGTON, June 17 -- Food and Drug Administration has issued a rule called: Medical Devices; Gastroenterology-Urology Devices; Classification of the Ingestible Gastrointestinal Blood Detection Capsule.

The rule was published in the Federal Register on June 17 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA) is classifying the ingestible gastrointestinal blood detection capsule 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 ingestible gastrointestinal blood detection capsule. We are taking this action because we hav...