Federal Register Proposed rule: FDA is proposing to reclassify from Class III to Class II (special controls) the automated blood cell separator device operating on a centrifugal separation principle and intended for the routine collection of blood and blood components. This proposed rule would also modify the special control for the device with the same intended use but operating on a filtration separation principle. FDA is making available a draft document entitled Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle dated January 2005 to serve as the special control. To download this guidance, click here. To view this notice, click here.
