Breast cancer diagnostic PMA review
This article was originally published in The Gray Sheet
Executive Summary
Premarket approval application for an immunohistochemical device indicated for the detection of HER2 overexpression in breast cancers will be reviewed at a joint meeting of FDA's Hematology and Pathology Devices and Immunology Devices Panels on Sep. 4. The meeting, which begins at 9:30 a.m., will be held at FDA's Corporate Building in Rockville, Maryland. For further information, contact CDRH's Veronica Calvin at 301/594-1243