FDA Permits CBE-30 for Reveos Implementation

The Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) has determined that implementation of the Reveos device for manufacturing blood components may be reported as a Changes Being Effected in 30 Days (CBE-30) supplement.

Last year, when blood establishments first began implementing the Reveos device, CBER considered the change a major modification requiring a Prior Approval Supplement (PAS). Following review of several submissions, CBER has determined that future implementations may be reported as a CBE-30.

Blood establishments with questions about current or future submissions may contact the Office of Blood Research and Review at CBEROBRRBPBInquiries@fda.hhs.gov.