AMDM
This article was originally published in The Gray Sheet
Executive Summary
In vitro diagnostic labeling, special 510(k)s, CLIA are among topics to be addressed at April 26-27 meeting in Rockville, Maryland. IVD 510(k) workshop will be held in conjunction with annual meeting April 25 at FDA. Agency speakers will explain 510(k) process, compliance issues. For more information, contact Greta Oehlert at 202/637-6837