Guidance for Industry and FDA Staff; Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle

In the special control guidance document, FDA recommends that manufacturers include in their annual reports a summary of adverse reactions that are maintained by the collecting or transfusing facility or similar reports of adverse events collected in addition to those required under the MDR regulation. The reporting of adverse device events summarized in an annual report will alert FDA to trends or clusters of events that might be a safety issue otherwise unreported under the MDR regulation.

The latest form for Guidance for Industry and FDA Staff; Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle expires 2028-03-31 and can be found here.