America’s Blood Centers (ABC) commends the Food and Drug Administration (FDA) for issuing the Final Guidance, Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method.
The guidance provides important recommendations for manufacturers seeking FDA approval of blood collection, processing, and storage systems used in the manufacture of blood components through the buffy coat method, and ABC appreciates FDA’s incorporation of recommendations submitted by the association in its 2024 comment letter on the draft guidance.
“America’s Blood Centers applauds FDA’s thoughtful consideration of stakeholder feedback and its commitment to developing a practical, science-based framework for the use of the buffy coat method for platelet production in the United States,” said Kate Fry, Chief Executive Officer of America’s Blood Centers. “We are particularly pleased that FDA incorporated key recommendations from ABC, including recognition of and support for the transition to DEHP-free blood collection systems, consideration of donor-related outlier events when evaluating residual red blood cell acceptance criteria, and acknowledgment that whole blood may be held for up to 24 hours after collection before component separation when supported by manufacturer’s directions for use. These changes will help facilitate innovation while maintaining the safety, quality, and availability of the nation’s blood supply.”
The association looks forward to continuing its collaboration with FDA to advance policies that foster innovation, strengthen the blood supply, and improve patient access to lifesaving blood products.