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Hematology/Pathology Devices Panel

This article was originally published in The Gray Sheet

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Executive Summary

FDA advisory panel meeting August 5 in Rockville, Maryland. Open committee discussion will cover a "points-to-consider document for automated cervical cancer slide readers and automated cervical cancer slide preparation instruments"; "home-use prothrombin time tests"; "standardization of coagulation assays and reagents"; "hematology replacement reagents"; and "a briefing on the FDA Immunohistochemical Products Workshop" held June 28-29. The panel will discuss general issues related to prothrombin time tests, not specific premarket approval applications, FDA says. For more information, call Larry Brindza at 301/594-2096

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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