FDA Responses: Licensure, Validation, and Donor Testing

This document includes a summary of two letters from the Food and Drug Administration (FDA) responding to questions from America’s Blood Centers (ABC). The questions represent concerns raised by ABC member blood centers relating to the licensure process, validation data, and donor testing. ABC’s first letter, sent to FDA on July 2, requested clarification on licensure, validation, and donor testing requirements. FDA responded to ABC’s letter on July 26. ABC’s second letter, sent on August 20, requested further clarification regarding donor testing requirements. FDA responded with its second letter on September 14.