BAXTER AUTOPHERESIS-C DOWNCLASSIFICATION RECOMMENDED BY BLOOD PRODUCTS PANEL; PETITION SUPPORTED BY LOW INCIDENCE OF ADVERSE EVENT DEVICE REPORTS
This article was originally published in The Gray Sheet
Executive Summary
Baxter's Autopheresis-C blood separation system's clinical safety record supports downclassification from Class III to Class II, FDA's Blood Products Advisory Committee concluded at a Sept. 27 meeting in Bethesda, Maryland.