America’s Blood Centers (ABC) has submitted comments to the U.S. Food and Drug Administration (FDA) in response to the agency’s October 2024 draft guidance titled, “Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method.” ABC’s buffy coat method comments were comprehensive and pointed out critical issues.
In the December 13th comments, ABC urged the need for, “feasible solutions to the implementation of the Buffy Coat Method (BC),” while raising concerns regarding, “significant operational issues [that] would impair implementation of the BC in the U.S. under the proposed draft guidance.” These buffy coat method comments highlight important aspects of the procedure.
ABC recommended that the FDA:
- “adopt alternate acceptance criteria for red blood cell components to accommodate outlier events; [and]
- approve holding whole blood for 24 hours at room temperature.”
Additionally, the comments noted that FDA should be aware that, “at this time, manufacturers are unlikely to seek to obtain FDA approval or clearance to market blood collection, processing, and storage systems intended for the manufacture of blood components for transfusion using the BC method, until they have implemented the European Union’s ban on di(2-ethylhexyl) phthalate (DEHP) in medical devices, effective in 2030.” These buffy coat method comments reflect the need for regulatory changes and industry readiness.
ABC expressed its appreciation that FDA, “is requiring manufacturers to ‘conduct appropriate clinical studies or submit existing clinical data to demonstrate the safety and efficacy of blood components prepared using the BC method.’ FDA’s acceptance of international data for use in the approval of new products or technologies reduces unnecessary and burdensome regulation to support innovation and blood product availability.” The full comments are available. These detailed buffy coat method comments reflect the thorough feedback provided by ABC.