In Brief: Neopath AutoPap
This article was originally published in The Gray Sheet
Executive Summary
Neopath AutoPap: Firm submits prospective clinical data requested by FDA in support of its pending premarket approval application supplement for use of the AutoPap as a primary Pap smear screener. At a September 1996 meeting, FDA's Hematology and Pathology Devices Panel recommended against approval of the PMA supplement and called for additional prospective studies comparing conventional cytologist slide review to AutoPap review ("The Gray Sheet" Oct. 7, 1996, p. 8). The automated Pap smear analysis system was approved in September 1995 for quality control rescreening of previously screened Pap smear slides...