Extracorporeal shock wave lithotripters
This article was originally published in The Gray Sheet
Executive Summary
Draft guidance to be used by FDA in support of downclassification to Class II of devices for use in fragmentation of kidney and ureteral calculi is released on the agency website Oct. 28. The guidance largely follows the suggestions of FDA's Gastroenterology and Urology Devices Panel, which recommended that only 20 patients at two sites be evaluated in clinical studies of the devices following downclassification ("The Gray Sheet" Aug. 3, p. 8)