510(k) Reform Does Not Mean Major Increase In Clinical Data Demands - FDA
This article was originally published in The Gray Sheet
Executive Summary
FDA insisted Aug. 31 that its planned reforms to the 510(k) program will not dramatically raise the bar for clinical data submissions
You may also be interested in...
AdvaMed Supports Splitting Up Class II Devices, But On Its Own Terms
Medical device makers are sending FDA a message that while they support some formal distinctions within the broad range of Class II devices, the creation of a "Class IIb" subset goes too far
AdvaMed Supports Splitting Up Class II Devices, But On Its Own Terms
Medical device makers are sending FDA a message that while they support some formal distinctions within the broad range of Class II devices, the creation of a "Class IIb" subset goes too far
New Lobby Will Advocate For VC Firms And Their Start-Ups
Frustrated by the lack of attention given to its constituency during the health care reform debate, the National Venture Capital Association announced Sept. 7 the formation of a new group to give innovators and start-ups a stronger voice in national affairs