FDA reclassifies lithotripters as lower risk citing new legislation to support decision
This article was originally published in Clinica
Executive Summary
The FDA proposed last week to reclassify extracorporeal shock wave lithotripters used to break up kidney and ureteral stones into a lower-risk category - from Class III to Class II. For the first time the agency invoked a provision in the FDA Modernization Act of 1997 (FDAMA) to support its decision.