Scrip is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


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Draft guidance to be used by FDA in support of downclassification to Class II of devices for use in fragmentation of kidney and ureteral calculi is released on the agency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)



Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts