FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; GASTROENTEROLOGY-UROLOGY DEVICES; CLASSIFICATION OF THE TEMPORARILY-PLACED URETHRAL OPENING SYSTEM FOR SYMPTOMS OF BENIGN PROSTATIC HYPERPLASIA

WASHINGTON, May 29 -- Food and Drug Administration has issued a rule called: Medical Devices; Gastroenterology-Urology Devices; Classification of the Temporarily-Placed Urethral Opening System for Symptoms of Benign Prostatic Hyperplasia.

The rule was published in the Federal Register on May 29 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA, Agency, or we) is classifying the temporarily-placed urethral opening system for symptoms of benign prostatic hyperplasia 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 temporarily-placed urethra...