IHC STAIN CRITERIA FOR OBTAINING CLASS II STATUS OUTLINED BY FDA
This article was originally published in The Gray Sheet
Executive Summary
IHC STAIN CRITERIA FOR OBTAINING CLASS II STATUS OUTLINED BY FDA in a July 20 draft "points to consider" document on premarket requirements for immunohistochemical stains. FDA's proposal to classify IHC in vitro diagnostics as Class II devices will be discussed at an Aug. 5 meeting of the FDA Hematology and Pathology Advisory Panel and at an Aug. 19 meeting of the FDA Immunology Advisory Panel ("The Gray Sheet" July 25, In Brief).