AdvaMed comments on CoA studies
This article was originally published in The Gray Sheet
Executive Summary
Trade association shows that of 22 condition-of-approval studies undertaken by members from 1998-2000, 16 were completed in the expected timeframe, two were completed late, two are ongoing, one was cancelled due to the indication being withdrawn and one failed because the device did not sell well enough to recruit participants. The survey, included in the group's FDL-1May comments to FDA, comes after the agency reported its own survey results on CoA studies for 45 devices that received PMA approval over the same timeframe. AdvaMed felt FDA unfairly characterized the "medical device industry as being substantially out of compliance" with CoA studies (1"The Gray Sheet" April 18, 2005, p. 14). "AdvaMed members...are in compliance with the PMA approval orders as issued or modified with the agreement of the agency," AdvaMed writes...