Medical devices; hematology and pathology devices: reclassification of automated blood cell separator device operating by centrifugal separation principle. Final rule.
The Food and Drug Administration (FDA) is reclassifying from class III to class II the automated blood cell separator device operating by centrifugal separation principle and intended for the routine collection of blood and blood components. FDA is taking this action on its own initiative based on new information. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special controls for this device, as well as the special controls for the device with the same intended use but operating on a filtration separation principle.
D001773:Blood Cells; D002469:Cell Separation / Q000295:instrumentation*; D002498:Centrifugation / Q000145:classification* / Q000295:instrumentation; D004867:Equipment Design; D004869:Equipment Safety / Q000145:classification*; D006405:Hematology / Q000145:classification / Q000295:instrumentation; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration