FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; GASTROENTEROLOGY-UROLOGY DEVICES; CLASSIFICATION OF THE NON-MEDICATED TOPICAL FORMULATION FOR TREATMENT OF ERECTILE DYSFUNCTION

WASHINGTON, July 27 -- Food and Drug Administration has issued a rule called: Medical Devices; Gastroenterology-Urology Devices; Classification of the Non-Medicated Topical Formulation for Treatment of Erectile Dysfunction.

The rule was published in the Federal Register on July 27 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA) is classifying the non-medicated topical formulation for treatment of erectile dysfunction 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 non-medicated topical formulation for treatment of er...