Extracorporeal shock wave lithotripters
This article was originally published in The Gray Sheet
Executive SummaryDraft 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)
You may also be interested in...
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
US FDA’s latest effort to provide guidance for consumers on pharmacogenomics tests underscores the challenges the agency faces in the absence of a clear regulatory framework for lab-developed tests – and with no easy mechanism to update labels for off-patent drugs.