HEMATOLOGY REPLACEMENT REAGENT CLEARANCE THROUGH "TRUNCATED" 510(K) PROCESS
This article was originally published in The Gray Sheet
Executive SummaryHEMATOLOGY REPLACEMENT REAGENT CLEARANCE THROUGH "TRUNCATED" 510(K) PROCESS recommended by FDA's Hematology and Pathology Devices Advisory Panel at an Aug. 5 meeting in Rockville, Maryland. Asked by FDA about the appropriate clearance mechanism for the devices, the panel suggested an abbreviated 510(k) that would compile some data in summary form. The data would aim to show that the "new reagent satisfies any known performance characteristics," panel member Brian Bull, MD, Loma Linda School of Medicine, California, noted.
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