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FDA reclassifies blood centrifuges

This article was originally published in The Gray Sheet

Executive Summary

FDA reclassifies from class III to class II (special controls) automated blood cell separator devices operating by centrifugal separation principal when intended for routine collection of blood and blood components on Nov. 30. The reclassification will become effective Dec. 31. An accompanying guidance document provides special controls for both filtration and centrifugal-based automated blood cell separators including the requirement for manufacturers to submit annual reports to FDA for three consecutive years following 510(k) clearance
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