REGULATORY UPDATE: FDA Seeks Comments on COI for Automated Blood Cell Separator Devices

May 22, 2024

The Food and Drug Administration is seeking comments on a collection of information (COI) concerning class II special controls for automated blood cell separator devices that operate by centrifugal or filtration separation principle.

Under FDA’s March 2011 guidance, manufacturers of currently marketed products not approved under the premarket approval process must submit reports that summarize adverse events experienced by users of the machines to FDA for three years.

Based on submissions to FDA over the last few years, the agency estimates that there are three manufacturers of automated blood cell separator devices that will spend approximately 5 hours preparing and submitting the annual report.

Additional information is available in the Federal Register notice