REGULATORY UPDATE: FDA Publishes Final Question-and-Answer Guidance for the Manufacture of Blood Components Using a Pathogen-Reduction Device

November 03, 2021

The Food and Drug Administration released a final guidance addressing the Manufacture of Blood Components Using a Pathogen-Reduction Device in Blood Establishments this week. The guidance, first published as a draft in December 2017, provides the agency’s recommendations for the most frequently asked questions in a concise, easy-to-read format.

AABB encourages readers to review the guidance in its entirety to support their compliance efforts. FDA specifically addresses recurring questions from blood establishments using a pathogen-reduction device, clarifying requirements for infectious disease testing and use of the Donor History Questionnaire. The guidance clarifies important information on a range of questions, including storage, use with specific components and quality control requirements. Members with additional questions may contact regulatory@aabb.org