FOOD AND DRUG ADMINISTRATION ISSUES PROPOSED RULE: GASTROENTEROLOGY-UROLOGY DEVICES; RECLASSIFICATION OF DIAGNOSTIC ENDOSCOPIC LIGHT SOURCE SYSTEMS TO BE RENAMED CYSTOSCOPIC SYSTEMS INTENDED AS AN AID FOR DETECTION OF BLADDER CANCER

WASHINGTON, Aug. 17 -- Food and Drug Administration has issued a proposed rule called: Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended as an Aid for Detection of Bladder Cancer.

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

Summary: The Food and Drug Administration (FDA) is proposing to reclassify diagnostic endoscopic light source systems (product code OAY), which are postamendments class III devices, from class III (premarket approval) into class II (special controls), subject to premarket notification. FDA is also proposing a new devi...