Test Makers Have One Year To Comply With New ASR Guidelines
This article was originally published in The Gray Sheet
Executive Summary
Diagnostic test makers will have until September 2008 to comply with newly clarified FDA policies for analyte specific reagents
You may also be interested in...
FDA Diagnostics Chief Predicts Multiple Warning Letters For ASR Violations
FDA expects to send out multiple warning letters to firms for illegally selling diagnostic products as 510(k)-exempt analyte specific reagents instead of as test kits, which are more heavily regulated
FDA Diagnostics Chief Predicts Multiple Warning Letters For ASR Violations
FDA expects to send out multiple warning letters to firms for illegally selling diagnostic products as 510(k)-exempt analyte specific reagents instead of as test kits, which are more heavily regulated
Contracting Out Gives Laboratories An In With Diagnostics Manufacturers
Manufacturers and laboratories have until September to begin complying with FDA's analyte specific reagent policy, clarified in 2007 guidelines. But some labs, particularly those specializing in molecular diagnostics, are scrambling to fill what could be a gap in needed supplies